Search Results for 'gemcitabine cisplatin'

A phase II trial of gemcitabine (G), cisplatin (C), and nab-paclitaxel (N) in advanced biliary tract cancers (aBTCs).

http://abstracts.asco.org/199/AbstView_199_187337.html

A phase I study of DKN-01 (D), an anti-DKK1 monoclonal antibody, in combination with gemcitabine (G) and cisplatin (C) in patients (pts) for first-line therapy with advanced biliary tract cancer (BTC).

http://abstracts.asco.org/199/AbstView_199_182654.html

Please note that information regarding clinical trials is being provided for informational purposes only. The Cholangiocarcinoma Foundation does not endorse any specific clinical trial. Please discuss any questions you may have about clinical trials with your healthcare provider.

Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancers

https://clinicaltrials.gov/ct2/show/NCT03144856

Please note that information regarding clinical trials is being provided for informational purposes only. The Cholangiocarcinoma Foundation does not endorse any specific clinical trial. Please discuss any questions you may have about clinical trials with your healthcare provider.

Purpose
This study is designed to see whether Apatinib is effective in treating patients with advanced refractory biliary tract cancers.

Condition Intervention Phase
Biliary Tract Cancer
Drug: Apatinib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Apatinib single agent
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Study of Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
Progression-free survival (PFS) [ Time Frame: Approximately 1 year ]
the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy

Secondary Outcome Measures:
Overall survival (OS) [ Time Frame: Approximately 2 years ]
Defined as the time from randomize to death

Disease control rate(DCR) [ Time Frame: Approximately 1 year ]
Defined as the rate of complete response , partial response and stable disease according to RECIST guidelines

Quality of life(QoL) [ Time Frame: Approximately 1 year ]
As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)

Safety (incidence of adverse events) [ Time Frame: Approximately 1 year ]
Incidence of adverse events

Estimated Enrollment: 39
Actual Study Start Date: February 22, 2017
Estimated Study Completion Date: March 1, 2019
Estimated Primary Completion Date: March 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apatinib group
Apatinib 500mg, po, QD, every 4 weeks.
Drug: Apatinib
Apatinib 500mg, po, qd, every 4 weeks.

Detailed Description:
Biliary tract cancers (BTC) includes cholangiocarcinoma and gallbladder carcinoma (GBC). The systematic treatment based on gemcitabine plus cisplatin is recommended as the current standard chemotherapy for unresectable or metastatic BTC. There is no standard recommendation for second line therapy.

Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2(VEGFR-2).

This study was conducted to assess the efficacy and safety of Apatinib in patients with advanced refractory BTC who had received first-line chemotherapy.

Eligibility

Ages Eligible for Study: 18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease.
Patients with ampullary carcinoma are not eligible.
Must have failed or are intolerant to one line of systemic treatment but no more than 2 prior lines of systemic chemotherapy for advanced BTC. Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible. If the patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing or having intolerance to one line of systemic chemotherapy used to treat the disease recurrence.
Age between 18 and 75 years old
Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment of 0 or 1.
Must have radiographic measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Life expectancy of at least 12 weeks (3 months).
For patients who have received prior radiation, cryotherapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met: 28 days have elapsed since that therapy; Lesions that have not been treated with local therapy must be present and measureable.
Must be able to understand and be willing to sign the written informed consent form. Must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study requirements.
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF) except for alopecia.
Adequate bone marrow, liver and liver function.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug.
Men and women of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug.
Exclusion Criteria:

Pregnant or lactating women;
History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
Uncontrolled hypertension;
Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;
Urine protein>grade 1;
Any factors that influence the usage of oral administration;
Patients with a clear tendency of gastrointestinal bleeding;
Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN);
Abuse of alcohol or drugs;
Less than 4 weeks from the last clinical trial;
Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy;
Active central nervous system (CNS). If CNS metastases are treated and potential participants are at neurologic baseline for at least 2 weeks prior to enrollment, they will be eligible but will need a Brain MRI prior to enrollment. 13. Disability of serious uncontrolled intercurrence infection.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03144856

Contacts
Contact: Feng-Hua Wang, MD, PhD 86-020-87342490 wangfh@sysucc.org.cn

Locations
China, Guangdong
Foshan people’s Hospital Recruiting
Foshan, Guangdong, China
Contact: Wei Wang 075783161035 m18038863618@163.com
Cancer center of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Fenghua Wang, MD, PhD 86-020-87342490 wangfh@sysucc.org.cn
Contact: Miao-Zhen Qiu, MD, PhD 86-020-87342490 qiumzh@sysucc.org.cn
Principal Investigator: Rui-Hua Xu, MD, PhD
Sponsors and Collaborators
Sun Yat-sen University
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Principal Investigator: Rui-Hua Xu, MD, PhD Sun Yat-sen University
More Information

Responsible Party: Fenghua Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03144856 History of Changes
Other Study ID Numbers: Apatinib_BTC
Study First Received: May 5, 2017
Last Updated: May 8, 2017
Individual Participant Data
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sun Yat-sen University:
Biliary Tract Cancer
Second line thrapy
Apatinib

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 12, 2017

I was operated on for CC on 23rd October 2015. Followed by radiation therapy and chemotherapy with gemcitabine and cisplatin. Five weeks after chemo ended the first CT scan was clear, 3 mos later CT was clear. Next CT was supposed to be after 6 more mos but I was feeling tummy pains so I asked for it to be done at four and a half months. That scan was clear, that was about a month ago. By my calculations I figured there was a 76% chance that I had beaten this thing.
.
On the 13th April I went to the ER with stomach pains. They found problems with my stomach but they also found a CA19-9 of 1197, two weeks later it is at 1643. By my calculations the CA19-9 probably started rising about three months ago.
.
PETscan last week found a hotspot in my pancreas. EUS-FNA is tomorrow.
.
I figure the new tumor is about 1.7cm in diameter. Maybe it can be resected but maybe not.
.
I am mad at my oncologist because she wasn’t tracking CA19-9. The full-body CTscans cost thousands of dollars while the CA19-9 is about $6. If they had caught this thing when it was the size of a BB I am sure my prognosis would be better.
.
Can anybody think of a reason why they wouldn’t track CA19-9 routinely?

Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors (ARCS-Multi)

https://clinicaltrials.gov/ct2/show/NCT03102320

Purpose
The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.

The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.

Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarcinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule).

Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor’s objective response rate. Radiological tumor assessments will be performed at defined time points until the patient’s disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for review and biomarkers.

Condition Intervention Phase
Neoplasms
Drug: Cisplatin
Drug: Gemcitabine
Drug: Anetumab ravtansine (BAY94-9343)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
Maximum tolerated dose (MTD) of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine in patients with mesothelin-expressing cholangiocarcinoma and pancreatic adenocarcinoma [ Time Frame: At least 3 weeks after the last patient starts treatment ]
The highest dose of anetumab ravtansine that can be given so that not more than 1 out of 6 patients experiences a DLT (during the DLT evaluation period) will be declared as the MTD for anetumab ravtansine in combination with cisplatin or with gemcitabine

Objective response rate (ORR) of anetumab ravtansine for monotherapy and combination therapy in mesothelin expressing advanced solid tumors [ Time Frame: 18 weeks after last patient starts treatment ]
A patient is a responder if the patient has a tumor response of CR or PR, as determined per RECIST 1.1 criteria (ITMIG modified RECIST 1.1 criteria for thymic carcinoma). In the Phase 1b portion of this study, the ORR is defined separately in each indication and mesothelin expression cohort, as the number of responders divided by the number of treated patients in the indication and mesothelin expression cohort

Secondary Outcome Measures:
Number of serious and non-serious adverse events (AEs) [ Time Frame: 18 weeks after last patient starts treatment ]
Include treatment-emergent AEs, SAEs, treatment-related AEs, AEs of special interest, and deaths.

Disease control rate (DCR) [ Time Frame: 18 weeks after last patient starts treatment ]
The DCR is defined as the number of patients with disease control divided by the number of treated patients.

Duration of response (DOR) [ Time Frame: Approximately 24 months after last patient starts treatment ]
DOR is defined in responders as the time from documentation of tumor response (CR or PR) to earlier of disease progression or death

Durable response rate (DRR) [ Time Frame: Approximately 24 months after last patient starts treatment ]
A durable responder is defined as a responder (CR or PR) with a duration of response per RECIST 1.1 criteria (ITMIG modified RECIST 1.1 criteria for thymic carcinoma) of 180 days or more. The DRR is the number of durable responders divided by the number of treated patients.

Progression free survival (PFS) [ Time Frame: Approximately 24 months after last patient starts treatment ]
PFS is defined as time from start of treatment until disease progression according to RECIST 1.1 (ITMIG modified RECIST 1.1 criteria for thymic carcinoma) or death.

Estimated Enrollment: 348
Anticipated Study Start Date: July 31, 2017
Estimated Study Completion Date: February 11, 2020
Estimated Primary Completion Date: May 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cholangiocarcinoma
Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with cisplatin During the main study phase anetumab ravtansine will be administered at the determined MTD in combination with cisplatin
Drug: Cisplatin
Cisplatin 25 mg/m2 IV administered on day 1 and day 8 of 21 day cycle, for up to maximum 6 cycles
Drug: Anetumab ravtansine (BAY94-9343)
Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered
Experimental: Adenocarcinoma of the pancreas
Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with gemcitabine During the main study phase, anetumab ravtansine will be administered at the determined MTD in combination with gemcitabine
Drug: Gemcitabine
Gemcitabine 1000 mg/m2 IV administered on days 1 and 8 of a 21-day cycle
Drug: Anetumab ravtansine (BAY94-9343)
Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered
Experimental: Other solid tumors
(Non-small cell adenocarcinoma of the lung (NSCLC adenocarcinoma), Adenocarcinoma of the breast – triple negative (TNBC), Gastric adenocarcinoma including gastroesophageal junction (GEJ Cancer, Thymic carcinoma) During the main study phase, anetumab ravtansine will be administered at dose of 6.5 mg/kg in solid tumors
Drug: Anetumab ravtansine (BAY94-9343)
Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Availability of tumor tissue for mesothelin expression testing
Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria)
At least one measurable lesion according to either Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or International Thymic Malignancy Interest Group (ITMIG) modified RECIST 1.1 as applicable
Adequate bone marrow, liver, renal and coagulation function
Left ventricular ejection fraction (LVEF) ≥ 50% of the lower limit of normal (LLN) according to local institutional ranges
Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria:

More than one prior anti-tubulin/microtubule agent
Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition
Symptomatic Central nervous system (CNS) metastases and/or carcinomatous meningitis
Contraindication to both CT and MRI contrast agents
Active hepatitis B or C infection
Pregnant or breast-feeding patients
Tumor type specific exclusion criteria
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03102320

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options ‘3’ or ‘4’) (+)1-888-84 22937

Show 57 Study Locations
Sponsors and Collaborators
Bayer
More Information

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03102320 History of Changes
Other Study ID Numbers: 15834
2016-004002-33 ( EudraCT Number )
Study First Received: March 30, 2017
Last Updated: April 5, 2017
Individual Participant Data
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
cholangiocarcinoma
pancreatic cancer
triple-negative breast cancer
non-small cell lung cancer
thymic carcinoma
gastric including gastroesophageal junction cancer

Additional relevant MeSH terms:
Gemcitabine
Cisplatin
Maytansine
Immunoconjugates
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on April 07, 2017

Not Yet Open.

Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma

Purpose
This study will evaluate two groups of patients who have intrahepatic cholangiocarcinoma. Each group will receive induction treatment with Cisplatin and Gemcitabine per SOC for 4 treatment cycles. Following induction treatment patients will be randomize (1:1), to 2 arms of treatment. One group (50%) will be receive high dose chemotherapy delivered specifically to the liver, while the other group (50%) will continue treatment with Cisplatin and Gemcitabine. Patient in each group will get repeating cycles of treatment until the cancer advances. All patients will be followed until death. This study will compare the overall survival (OS) in patients with intrahepatic cholangiocarcinoma.

Condition Intervention Phase
Bile Duct Cancer
Intrahepatic Cholangiocarcinoma
Combination Product: Melphalan/HDS
Drug: Cisplatin and Gemcitabine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine Versus Cisplatin/Gemcitabine in Patients With IntraHepatic Cholangiocarcinoma

Resource links provided by NLM:

Genetics Home Reference related topics: cholangiocarcinoma
Drug Information available for: Melphalan Melphalan hydrochloride Cisplatin Gemcitabine Gemcitabine hydrochloride
Genetic and Rare Diseases Information Center resources: Intrahepatic Cholangiocarcinoma Bile Duct Cancer
U.S. FDA Resources

Further study details as provided by Delcath Systems Inc.:

Primary Outcome Measures:
Overall Survival [ Time Frame: Change in survival is being assessed through study completion, an average of 2 years ]
Patients will be followed until death

Secondary Outcome Measures:
Progression-free survival, as determined by IRC [ Time Frame: Change in PFS change will be assessed every 9 weeks through study completion, an average of 1 year ]
Period of time from 1st treatment to tumor progression or death

Objective response rate (CR + PR) as determined by the Investigator [ Time Frame: ORR change will be assessed every 9 weeks through study completion, an average of 1 year ]
The number of patients with either a complete or partial response as determined by the investigator

Other Outcome Measures:
Progression-free survival, as determined by the Investigator [ Time Frame: PFS change will be assessed every 9 weeks through study completion, an average of 1 year ]
Period of time from 1st treatment to tumor progression

Objective response rate as determined by IRC [ Time Frame: ORR change will assessed every 9 weeks through study completion, an average of one year ]
The number of patients with either a complete or partial response as determined by the IRC

Quality of Life (QOL) as measured by the functional health survey EQ-5D module [ Time Frame: QOL change will be evaluated every 6 weeks through study completion, an average of 1 year ]
QoL will be evaluated for all patients treated in the study

Pharmacokinetic Outcome Measures: Cmax [ Time Frame: PK is assessed at each Melphalan/HDS cycle approximately every 6 weeks for an average of one year ]
Observed maximum concentration (Cmax)

Pharmacokinetic Outcome Measures: AUC [ Time Frame: PK is assessed at each Melphalan/HDS cycle approximately every 6 weeks for an average of one year ]
Area under the curve (AUC)

Pharmacokinetic Outcome Measures: Tmax [ Time Frame: PK is assessed at each Melphalan/HDS cycle approximately every 6 weeks for an average of one year ]
Time of maximum concentration (Tmax)

Pharmacokinetic Outcome Measures: CL [ Time Frame: PK is assessed at each Melphalan/HDS cycle approximately every 6 weeks for an average of one year ]
Total system clearance (CL)

Incidence of Treatment-Emergent Adverse Events (Safety) [ Time Frame: Adverse events are assessed from time of informed consent through the study completion, average about 1 year ]
Number of patients experiencing treatment related adverse events as assessed by CTCAE version 4.0

Estimated Enrollment: 295
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: May 2023
Estimated Primary Completion Date: January 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melphalan/PHP
Patients may receive up to 6 treatments of Melphalan/HDS 3.0 mg/kg IBW. Each treatment cycle consists of 6 weeks with an acceptable delay for an additional 2 weeks (i.e. 8 weeks in total). The maximum dose of melphalan will be 220 mg per treatment.
Combination Product: Melphalan/HDS
Melphalan/HDS treatment for up to six cycles, followed by a re-induction of CisGem.
Other Name: Melphalan/PHP
Active Comparator: Cisplatin and Gemcitabine
Each Cis/Gem treatment cycle will comprise cisplatin, dosed at 25 mg per square meter of body surface area, and gemcitabine, dosed at 1000 mg per square meter of body surface area. Each will be administered on Days 1 and 8 every 3 weeks.
Drug: Cisplatin and Gemcitabine
continuous treatment with Cis/Gem until disease progression
Other Name: Cis/Gem

Detailed Description:
The study will consist of 4 phases: a screening, an induction, randomization and follow-up phase.

Screening phase: Screening assessments will be conducted within 28 days prior to initiation of Induction Phase treatment to determine each patient’s overall eligibility. These assessments will include medical history; physical examination; Eastern Cooperative Oncology Group (ECOG) performance status (PS); 12 lead electrocardiogram (ECG); echocardiogram (ECHO); vital signs; laboratory assessments; radiologic assessments of disease status; and an evaluation of the vasculature compatibility for Percutaneous Hepatic Perfusion (PHP).

Induction phase: The initial 12 weeks of the study, all patients will receive 4 cycles of cisplatin/gemcitabine. Each cycle will be comprised of cisplatin dosed at 25 mg per square meter of body-surface area (BSA), followed by gemcitabine dosed at 1000 mg per square meter of BSA; dosing will occur on Days 1 and 8 of each cycle. At the completion of 3 cycles (week 8 (+1 week)) of cisplatin/gemcitabine, an imaging scan is performed as per standard of care to determine if the patient has progressed on treatment or should continue receiving the cisplatin/gemcitabine induction therapy for one more cycle (4th cycle – prior to randomization). At the completion of 4 cycles (week 12 (+1 week)) of cisplatin/gemcitabine, patients will undergo whole-body imaging to determine the status of their disease. Patients with progressive disease (PD) will be discontinued from study treatment, and will receive further treatment to be determined by the principal investigator (PI). They will continue to be followed until death or the end of the study. Patients who have at least stable disease (SD) at imaging after induction phase of 4 cycles of cisplatin/gemcitabine (week 12 (+ 1 week)) will go on to the next phase of the study (Randomized Treatment Phase).

Randomization phase: Patients who have at least stable disease via imaging at the end of the Induction Phase will be randomized in a 1:1 ratio to Melphalan/HDS treatment or to continue cisplatin/gemcitabine in cycles previously described in the Induction Phase, until progressive disease (PD) or unacceptable toxicity is observed. Patients who were randomized to treatment with Melphalan/HDS (dosed at 3.0 mg/kg Ideal Body Weight [IBW]) must undergo their first treatment within 14 days following the whole body imaging performed at end of the Induction Phase. For Melphalan/HDS treatment, patients will receive up to 6 treatments. Each treatment cycle will consist of 6 weeks with an acceptable delay for up to another 2 weeks before the next planned treatment to allow for additional recovery, if needed. After the Melphalan/HDS treatment, in the absence of disease progression, the patient should undergo a re-induction of CisGem. Tumor response will be assessed in both treatment arms every 8 weeks (+ 1 week) until PD.

The assessment scans will be reviewed by Independent Review Committee (IRC). At any time when PD is observed, the patient will be removed from further study treatment; any further treatment will be at the discretion of the investigator. Melphalan/HDS treatment will also be discontinued in the event that recovery requires more than 8 weeks from last treatment. An end-of-treatment visit will be conducted approximately 6 to 8 weeks following the final dose of study treatment. Ongoing adverse events (AEs) at the end-of-treatment visit will be followed until the severity returns to common terminology criteria for adverse events (CTCAE) Grade < 1. Follow-up phase: In the event that disease has not progressed at the end-of-treatment visit, disease assessment scans will continue every 8 weeks (+ 1 week) until PD is documented. Patients will be contacted by phone every 6 months for survival status for the first two years following the completion of study treatment, then yearly thereafter until death, withdrawal of informed consent or they become lost to follow-up, whichever occurs first. Patients will be monitored for two years following the completion of study treatment for the development of myelodysplasia and secondary leukemia. Eligibility Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Are willing and able to provide signed informed consent.
Intrahepatic cholangiocarcinoma diagnosed by histology.
Unresectable ICC, with less than 50% of the liver involved, and without clinically significant extra-hepatic disease (regional lymph node lesions [≤ 2 cm] are acceptable) based on CT
Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and liver) must be performed within 28 days prior to initiation of Induction Phase treatment.
At least one target lesion based on the evaluation criteria in solid tumors (RECIST 1.1).
Patients must have an ECOG PS of 0-1 at screening.
Male or female patients aged ≥ 18 years.
Patients must weigh ≥ 35 kg (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).
Exclusion Criteria:

Greater than 50% tumor burden in the liver by imaging.
History of orthotopic liver transplantation, hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting. Prior Whipple procedure is permitted provided the anatomy is still compatible for perfusion with the Melphalan/HDS system.
History of, or known, hypersensitivity to any components of melphalan or the components of the Melphalan/HDS system.
History of, or known, hypersensitivity to gemcitabine or platinum-containing compounds.
Known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
Prior treatment with gemcitabine or platinum-containing compounds, including in the adjuvant setting.
Received an investigational agent for any indication within 30 days prior to first treatment.
Prior radiation therapy to the liver including 90Y , I131 based loco regional therapy. Prior loco regional therapy, including resection, based on other technology for ICC, if any, must have been completed at least 4 weeks prior to baseline imaging.
Not recovered from side effects of prior therapy to ≤ Grade 1 (according to National Cancer Institute [NCI] CTCAE version 4.03). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at > Grade 1.
Those with New York Heart Association functional classification II, III or IV; active cardiac conditions including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.
History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
Patients with active bacterial infections with systemic manifestations (malaise, fever, leukocytosis) are not eligible until completion of appropriate therapy. Patients taking low-dose antibiotics for biliary obstruction are exempted from this exclusion criterion.
History of prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously).
Acute or active hepatitis B or hepatitis C infection. Patients with anti-hepatitis B core antigen (HBc) positive, or hepatitis B surface antigen (HBsAg) but viral deoxyribonucleic acid (DNA) negative are exception(s).
History of bleeding disorders which would put a patient at risk for bleeding with anti-coagulation or patients with an increased risk of thromboembolic or hemorrhagic events (e.g., stroke).
Brain lesions or intracranial abnormalities at risk for bleeding, by history or radiologic imaging (e.g., active metastases).
Known varices at risk of bleeding, including medium or large esophageal or gastric varices, or active peptic ulcer.
Inadequate hematologic function as evidenced by any of the following:
Platelets < 100,000/µL
Hemoglobin < 10.0 g/dL, independent of transfusion or growth factor support
White blood cell count (WBC) < 2,000/µL
Neutrophils < 1,500 cells/µL.
Serum creatinine > 1.5 mg/dL. If serum creatinine > 1.5 mg/dL, the measured creatinine clearance must be measured and patient is eligible if creatinine clearance > 45 mL/min.
Inadequate liver function as evidenced by any of the following:
Total serum bilirubin > 1.5 times ULN
Aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) or alanine aminotransferase (ALT) > 5 times ULN
Serum albumin < 2.9 g/dL.
Known alcohol or drug abuse that would preclude compliance with study procedures.
For female patients of childbearing potential (defined as having had a menstrual period within the past 12 months): a positive serum pregnancy test (β-human chorionic gonadotropin [β HCG]) within 7 days prior to enrollment; or unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment; or if breastfeeding, unwilling or unable to stop breastfeeding while on study treatment.
Sexually active females of childbearing potential and sexually active males with partners of reproductive potential: unwilling or unable to use appropriate contraception from screening until at least 6 months after last administration of study treatment.
Patients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.
Patients with biliary stents.
Patients with a history of external percutaneous transhepatic cholangiography catheter placement.
Patients previously treated with any intra-arterial regional hepatic therapy such as trans-arterial chemoembolization.
Patients with severe allergic reactions to iodine contrast which cannot be controlled by premedication with antihistamines and steroids.
Patients with a latex allergy
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03086993

Contacts
Contact: LESLIE CALLAHAN, BSN, MS 212-489-2100 ext 247 LCALLAHAN@DELCATH.COM
Contact: LARS BIRGERSON, MD lbirgerson@delcath.com

Sponsors and Collaborators
Delcath Systems Inc.
More Information

Responsible Party: Delcath Systems Inc.
ClinicalTrials.gov Identifier: NCT03086993 History of Changes
Other Study ID Numbers: PHP-ICC-203
Study First Received: March 13, 2017
Last Updated: March 21, 2017
Individual Participant Data
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Cholangiocarcinoma
Bile Duct Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Cisplatin
Melphalan
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on March 23, 2017

Not Yet Open.

Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

Purpose
There is no proven adjuvant treatment after curative surgical resection in patients with cholangiocarcinoma, although previous meta-analysis suggested potential survival benefit of adjuvant chemotherapy or radiotherapy in patients with lymph node-positive resected cholangiocarcinoma. Despite of lack of level 1 evidence and no data which regimen is optimal, adjuvant chemotherapy is widely used in daily practice setting. Based on this background, the investigators designed the randomized phase 2 trial comparing capecitabine and gemcitabine plus cisplatin in patients with resected lymph node-positive extrahepatic cholangiocarcinoma.

Condition Intervention Phase
Cholangiocarcinoma
Biliary Tract Cancer
Adjuvant Chemotherapy
Capecitabine
Gemcitabine
Cisplatin
Drug: Gemcitabine plus cisplatin
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Study of Capecitabine vs Gemcistabine Plus Cisplatin in Patients With Resected Extrahepatic Cholangiocarcinoma With Regional Lymph Node Metastasis

Resource links provided by NLM:

Genetics Home Reference related topics: cholangiocarcinoma
Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Capecitabine
Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer
U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
2-year disease-free survival [ Time Frame: 2 years ]
Proportion of patients without disease recurrence after 2 years

Secondary Outcome Measures:
Disease-free survival [ Time Frame: 4 years ]
Median time point that 50% of study patients recur

Toxicities (Adverse events related with chemotherapy) [ Time Frame: 4 years ]
Adverse events related with chemotherapy

Overall survival [ Time Frame: 4 years ]
Median time point that 50% of study patients is alive

Estimated Enrollment: 100
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Capecitabine
Adjuvant Capecitabine
Drug: Capecitabine
Capecitabine 1,250 mg/m2 Day 1 to 14, every 3 weeks
Experimental: Gemcitabine plus cisplatin
Adjuvant Gemcitabine plus Cisplatin
Drug: Gemcitabine plus cisplatin
Gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 Day 1 and 8, every 3 weeks
Other Name: Gemcitabine and cisplatin

Eligibility

Ages Eligible for Study: 19 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Patients aged 19 years and older
Histologically documented extrahepatic cholangiocarcinoma (perihilar or distal bile duct tumor)
Microscopic or macroscopic surgical resection (ie., R0 or R1 resection)
Regional lymph node metastasis according to the American Joint Committee on Cancer (AJCC) 7th edition
No distant metastasis
Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 1
No prior chemotherapy or radiotherapy
Serum CA 19-9 < 100 U/mL at the time of enrollment
Adequate bone marrow function as defined by platelets ≥ 100 x 109/L and neutrophils ≥ 1.5 x 109/L
Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN)
Adequate hepatic function with serum total bilirubin < 2 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN
No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other non life-threatening cancer (i.e., prostate or thyroid cancer) except where treated with curative intent > 5 years previously without evidence of relapse Written informed consent to the study
Exclusion Criteria:

Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or to complete the protocol or a history of non-compliance
Histologies other than adenocarcinoma such as mixed hepatocellular carcinoma/cholangiocarcinoma, adenosquamous carcinoma or mixed adenocarcinoma/neuroendocrine carcinoma
Intrahepatic cholangiocarcinoma or gallbladder cancer
Obstruction of gastrointestinal tract
Active gastrointestinal bleeding
Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol
Female subjects who are pregnant or lactating, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving study drug until 3 months after receiving the last dose of study drug. A highly effective method of contraception is defined as having a low failure rate (< 1% per year) when used consistently and correctly.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03079427

Contacts
Contact: Chanhoon Yoo, MD +82-2-3010-1727 yooc@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Baek-Yeol Ryoo, MD Asan Medical Center
More Information

Publications:
Horgan AM, Amir E, Walter T, Knox JJ. Adjuvant therapy in the treatment of biliary tract cancer: a systematic review and meta-analysis. J Clin Oncol. 2012 Jun 1;30(16):1934-40. doi: 10.1200/JCO.2011.40.5381. Review.
Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators.. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
Ramírez-Merino N, Aix SP, Cortés-Funes H. Chemotherapy for cholangiocarcinoma: An update. World J Gastrointest Oncol. 2013 Jul 15;5(7):171-6. doi: 10.4251/wjgo.v5.i7.171.
Neoptolemos JP, Moore MJ, Cox TF, Valle JW, Palmer DH, McDonald AC, Carter R, Tebbutt NC, Dervenis C, Smith D, Glimelius B, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Ghaneh P, Halloran CM, Lerch MM, Oláh A, Rawcliffe CL, Verbeke CS, Campbell F, Büchler MW; European Study Group for Pancreatic Cancer.. Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs observation on survival in patients with resected periampullary adenocarcinoma: the ESPAC-3 periampullary cancer randomized trial. JAMA. 2012 Jul 11;308(2):147-56. doi: 10.1001/jama.2012.7352. Erratum in: JAMA. 2012 Nov 14;308(18):1861.
Patt YZ, Hassan MM, Aguayo A, Nooka AK, Lozano RD, Curley SA, Vauthey JN, Ellis LM, Schnirer II, Wolff RA, Charnsangavej C, Brown TD. Oral capecitabine for the treatment of hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma. Cancer. 2004 Aug 1;101(3):578-86.
Petekkaya I, Gezgen G, Roach EC, Solak M, Gullu I. Long-term advanced cholangiocarcinoma survivor with single-agent capecitabine. J BUON. 2012 Oct-Dec;17(4):796.

Responsible Party: Baek-Yeol Ryoo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03079427 History of Changes
Other Study ID Numbers: Asan-ONCHBP-2017-001
Study First Received: March 9, 2017
Last Updated: March 13, 2017
Individual Participant Data
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Hello,

Don’t even know where to start our lives have been turned upside down the last few months. What started out as what we thought was a gallbladder attack a few days before Christmas has turned into our worst nightmare.

My husband is 55 and was diagnosed in Jan with stage 4 Intrahepatic Cholangiocarinoma with mets to the lungs. We have a 11 year old son who is taking this very hard.

We did go to Mayo Clinic in Rochester MN for a second opinion and they gave us the same thing do nothing and live 3 months do chemo and maybe 1 year.

So we are here at home doing chemo-Cisplatin and Gemcitabine. So far he is taking this pretty good just really tried and not wanting to eat much. He is done with the first round of chemo and he is going for his first ct scan this week. We are holding our breath hoping for the best.

We are also talking with MD Anderson in Texas on the phone about maybe going down there for treatment. Where we live is very rural not uptodate on treatments so it’s very hard to get newer treatments around our area. I look online and ask the Dr. about giving my husband certain vit. like vit D3, Vit C, Folic Acid and all he says you can if you want. Then I asked if we could talk to a nutritionist and he set up the appt. and the lady was talking to us just fine about good foods and then asked what stage he was and we told her stage 4 and then she said if he wants a snickers candy bar for lunch have one, go thru McDonalds drivethru. We left soon after that.

Sorry to be rambling on I haven’t had anyone to talk to about this. I took care of both of my parents who died of cancer I never thought in a million years I would be doing the same with my husband.

A case report of posterior reversible encephalopathy syndrome in a patient receiving gemcitabine and cisplatin.

https://www.ncbi.nlm.nih.gov/pubmed/28225482

Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer

Not yet open.

https://clinicaltrials.gov/ct2/show/NCT03046862

Purpose
The dynamics of immune systems by cytotoxic chemotherapy and its changes by combination with immuno-oncology agents will be uncovered.

The combination of Durvalumab/Tremelimumab with gemcitabine/cisplatin chemotherapy is feasible and efficacious in chemo-naïve biliary tract cancer.

Combination of anti-L1 cell adhesion molecule antibody and gemcitabine or cisplatin improves the therapeutic response of intrahepatic cholangiocarcinoma.

https://www.ncbi.nlm.nih.gov/pubmed/28166242