Search Results for 'gemcitabine cisplatin'

Stereotactic Body Radiation Therapy for Unresectable Perihilar Cholangiocarcinoma (STRONG)

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

Currently Recruiting

https://clinicaltrials.gov/ct2/show/NCT03307538

PurposeRationale:

For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients the tumors are found to be unresectable at presentation due to local invasive tumor growth or the presence of distal metastases. For patients with unresectable cholangiocarcinoma palliative chemotherapy is the standard treatment yielding an estimated median overall survival of 12-15.2 months. There is no evidence from randomized trials that support the routine use of stereotactic body radiation therapy (SBRT) for cholangiocarcinoma. However, small and most often retrospective studies combining chemotherapy with SBRT showed promising results with overall survival reaching up to 33-35 months.

Based upon these observations, the investigators designed a local feasibility trial with SBRT after chemotherapy in patients with unresectable perihilar cholangiocarcinoma in order to try to confirm the observed tolerability of adding SBRT to standard chemotherapy. The expected time to include the required patients for this pilot study will be one year.

Objective:

To assess feasibility of SBRT as add on treatment after standard chemotherapy.

Study design:

Local feasibility trial.

Study population:

Patients diagnosed with perihilar cholangiocarcinoma, 18 years of age or older, T1-4 N0-1 M0 (AJCC 7th Edition), after completion of standard chemotherapy. Exclusion criteria are local tumor growth into either stomach, colon, duodenum, pancreas or abdominal wall. Sample size will be 6 patients.

Intervention:

SBRT will be delivered in 15 fractions of 3 to 4.5Gy after 8 cycles of chemotherapy. In case of toxicity causing premature termination of systemic treatment, the patient can still proceed to SBRT.

Main study parameters/endpoints:

The primary endpoint of this study is feasibility measured by radiotherapy induced toxicity according to CTC v4.0.3.

Secondary endpoints will be:

Quality of life
Local progression
Progression free survival
Overall survival
Cellular radiosensitivity.

Condition
Intervention
Klatskin Tumor
Radiation: Stereotactic body radiation therapy

Study Type:
Interventional
Study Design:
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:
A Pilot Study to Determine the Feasibility of Stereotactic Body Radiation Therapy Following Chemotherapy for Unresectable Perihilar Cholangiocarcinoma. “The STRONG Trial”

Resource links provided by NLM:

Genetics Home Reference related topics: cholangiocarcinoma
Genetic and Rare Diseases Information Center resources: Bile Duct Cancer Klatskin Tumor
U.S. FDA Resources

Further study details as provided by Alejandra Mendez Romero, Erasmus Medical Center:

Primary Outcome Measures:Acute toxicity [ Time Frame: 3 months ]Limiting toxicity will be defined as more than one patient with grade 4 hepatobiliary toxicity related to study procedures, or more than one patient with grade 3 gastrointestinal toxicity related to study procedures, occurring in the period up to 3 months after the last SBRT administration.

Secondary Outcome Measures:Quality of life [ Time Frame: 2 years ]Assessed by means of the EORTC QLQ-C30 questionnaire

Quality of life [ Time Frame: 2 years ]Assessed by means of the EORTC QLQ-BIL21 questionnaire

Quality of life [ Time Frame: 2 years ]Assessed by means of the EuroQoL-5D questionnaire

Local progression [ Time Frame: 2 years ]Measured on CT

Local progression [ Time Frame: 2 years ]Measured on MRI

Progression free survival [ Time Frame: 2 years ]Time from treatment to progression measured on CT

Overall survival [ Time Frame: 2 years ]

Cellular radiosensitivity [ Time Frame: 2 years ]A predictive assay will be developed for radiotherapy response of both normal and tumor tissue by establishing normal tissue and tumor organoids and determining several key parameters for their response to ionizing radiation treatment.

Estimated Enrollment:
6
Actual Study Start Date:
September 1, 2017
Estimated Study Completion Date:
December 2020
Estimated Primary Completion Date:
September 2018 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Experimental: Stereotactic body radiation therapy
Radiation: Stereotactic body radiation therapy15 fractions of 3-4,5 Gy (risk-adapted)

Detailed Description:For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients the tumors are found to be unresectable at presentation due to local invasive tumor growth or the presence of distant metastases. For these patients palliative chemotherapy is the standard treatment yielding an estimated median overall survival of 12-15.2 months. There is no evidence from randomized trials that supports the routine use of stereotactic body radiation therapy (SBRT) for unresectable cholangiocarcinoma. However, small and most often retrospective studies combining chemotherapy with SBRT showed promising results with overall survival reaching up to 33-35 months.

This pilot study is designed as a first step to confirm and extend these findings. Up to six patients diagnosed with unresectable perihilar cholangiocarcinoma will be treated with standard chemotherapy followed by SBRT in order to assess possible severe side effects of the treatment. As part of this research, patients will be followed with CT- or MRI-scan and blood tests exams until progression. In addition to this clinical evaluation, the investigators will also work towards developing a predictive assay for radiotherapy response of both normal and tumor tissue by establishing normal tissue and tumor organoids and determining several key parameters for their response to ionizing radiation treatment.
Eligibility
Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

In order to be eligible to participate in this study, a subject must be discussed in a multidisciplinary liver tumor board and should meet all of the following criteria:

Patients diagnosed with perihilar cholangiocarcinoma according to the criteria of the Mayo Clinic, Rochester:

Positive or strongly suspicious intraluminal brush or biopsy or,
A radiographic malignant appearing stricture plus either:

CA 19-9>100 U/ml in the absence of acute bacterial cholangitis, or
polysomy on FISH, or
a well-defined mass on cross sectional imaging.
One tumor mass
Unresectable tumor
Finished chemotherapy treatment with Gemcitabine and Cisplatin, preferably 8 cycles. If less cycles are given, patients are still eligible for this study.
T1-T4 (AJCC staging 7th edition), before chemotherapy
N0-N1 (AJCC staging 7th edition), radiologically or pathologically suspect, before chemotherapy
Measurable disease to be selected as a target on CT/MRI-scan, according to RECIST criteria, after chemotherapy within 6 weeks prior to inclusion
Tumor visibility on CT
If liver cirrhosis is present, it should be well compensated, with Child-Pugh grade A.
Age ≥ 18 years
ECOG performance status 0-1
Bilirubin ≤1.5 times normal value, AST/ALT ≤5 times ULN, within 6 weeks prior to inclusion
Platelets ≥ 50x10E9/ l, Leukocytes > 1.5x10E9/l, Hb > 6 mmol/l, within 6 weeks prior to inclusion
Written informed consent, after chemotherapy
Willing and able to comply to the follow-up schedule
Able to start SBRT within 12 weeks after completion of chemotherapy.
Exclusion criteria:

Eligibility for resection
Prior surgery or transplantation
Multifocal tumor
Tumor extension in stomach, colon, duodenum, pancreas or abdominal wall.
N2, (AJCC staging 7th edition), radiologically or pathologically suspect, before chemotherapy
Distant metastases
Progression (local or distant) during or after chemotherapy Ascites
Previous radiotherapy to the liver
Current pregnancy
Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307538

Contacts

Contact: Alejandra Méndez Romero, MD, PhD
+31 (0)10 7035829
a.mendezromero@erasmusmc.nl

Contact: Merel Koedijk, MD
+31 (0)10 7041335
m.koedijk@erasmusmc.nl
Locations

Netherlands
Erasmus MC
Recruiting
Rotterdam, Zuid Holland, Netherlands, 3015 CE
Contact: Alejandra Mendez Romero, MD PhD    +31 (0)10 7035829    a.mendezromero@erasmusmc.nl
Principal Investigator: Alejandra Mendez Romero, MD, PhD
Sponsors and Collaborators
Erasmus Medical Center
Investigators

Principal Investigator:
Alejandra Méndez Romero, MD, PhD
Erasmus Medical Center
More Information

Responsible Party:
Alejandra Mendez Romero, A. Méndez Romero MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT03307538     History of Changes
Other Study ID Numbers:
NL 60588.078.17

First Submitted:
September 26, 2017
First Posted:
October 11, 2017
Last Update Posted:
October 11, 2017
Last Verified:
October 2017
Individual Participant Data (IPD) Sharing Statement:
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 Alejandra Mendez Romero, Erasmus Medical Center:
Perihilar cholangiocarcinoma
Klatskin tumor
Stereotactic body radiation therapy

Additional relevant MeSH terms:
Cholangiocarcinoma
Klatskin Tumor
Adenocarcinoma
Carcinoma

Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Biliary Tract Cancers (FBI-TRAC)

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.

Currently Recruiting.

https://clinicaltrials.gov/ct2/show/NCT03291899

PurposeThis study is to evaluate the response rate and toxicity profile of infusional 5 fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFIRINOX) in first-line treatment of advanced biliary tract cancers and also to assess progression free survival and overall survival of FOLFIRINOX in first line treatment of advanced biliary tract cancers

Condition
Intervention
Phase
Biliary Tract Cancer
Combination Product: FOLFIRINOX
Phase 2

Study Type:
Interventional
Study Design:
Intervention Model: Single Group Assignment
Intervention Model Description:Simon 2-stage optimum design Model
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:
Phase II Trial of Infusional 5 FLUOROURACIL, LEUCOVORIN, OXALIPLATIN AND IRINOTECAN (FOLFIRINOX) in First Line Treatment of Advanced Biliary Tract Cancers

Resource links provided by NLM:

Drug Information available for: Fluorouracil Oxaliplatin Irinotecan
Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer
U.S. FDA Resources

Further study details as provided by Shouki Bazarbashi, King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:Response rate [ Time Frame: 3 year ]Evaluate the response rate using RECIST 1.1 criteria

Secondary Outcome Measures:progression free survival [ Time Frame: 4 years ]calculated from day 1 of chemotherapy till either progression, death or date of last follow up whichever comes first

overall survival [ Time Frame: 4 years ]calculated from day 1 of chemotherapy till either death or date of last follow up whichever comes first

Estimated Enrollment:
32
Actual Study Start Date:
January 3, 2017
Estimated Study Completion Date:
August 2020
Estimated Primary Completion Date:
August 2019 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Experimental: Experimental single armChemotherapy using the FOLFIRINOX regimen will be given every 2 weeks for a total of 12 cycles. FOLFIRINOX consist of:

Oxaliplatin-85 mg/m2 IV Day 1
Leucovorin-400 mg/m2 IV Day 1
Irinotecan-180 mg/m2 IV Day 1
Fluorouracil (FU)-400 mg/m2 IV bolus Day 1
Fluorouracil 2400 mg/m2 infused over 46 hours starting day 1
Combination Product: FOLFIRINOXcombination chemotherapy using Oxaliplatin, Irinotecan, Leucovorin and Fluorouracil, given every 15 days for a total of 12 cycles

Show Detailed Description

Eligibility
Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:
19 Years and older   (Adult, Senior)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Criteria
Inclusion Criteria:

Histologically confirmed locally advanced (irresectable) or metastatic biliary tract cancers.
Measurable disease. Defined as tumor that have uni or bi dimensional measurement not less than 1.5 cm on any dimension.
Age ≥ 18 years.
Signed written informed consent before enrolment.
No prior chemotherapy or anti-neoplastic therapy other than radiotherapy more than 4 weeks prior to enrolment and to areas other than the measurable disease.
Patients of either sex or child bearing age must be willing to use adequate contraceptive measures during the study and for 6 months after treatment.
Life expectancy of 6 months or more.
Eastern Cooperative Oncology Group performance status of 0-1.
Adequate renal function: creatinine within normal institutional range.
Adequate hepatic function: Total bilirubin within normal institutional limits, serum aspartate aminotransferase and alanine aminotransferase levels ≤2.5 times the institutional upper limit of normal or ≤ 5 times the institutional upper limit of normal of elevated because of liver involvement.
Adequate hematological values: leukocyte count ≥3.0 x 109/L, an absolute neutrophil count ≥1.5 x 109/L, a platelet count ≥100 x 109/L.
Exclusion Criteria:

Known or suspected dihydropyrimidine deficiency.
Presence of central nervous system metastasis.
Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer.
Severe cardiovascular disease (congestive heart failure New York Heart Association class three or four, unstable angina pectoris, myocardial infarction or significant arrhythmias).
Psychiatric or mental disorder, precluding understanding of the information of the trial related topics and giving valid informed consent.
Active uncontrolled infection.
Pregnant patients (confirmed by β-Human chorionic gonadotrophin test where appropriate).
Serious underlying medical condition (in the judgement of the investigator) which could impair the ability of the patient to participate in the trial.
Any psychological, familial, geographic or social circumstances which could impair the patient’s ability to participate in the trial and comply with follow up.
Treatment with other experimental drugs within 30 days of entry into the trial.
Treatment with other anti-cancer therapy.
Known hypersensitivity to any of the study drugs.
Breast feeding
Legal incapacity.
Patients with a known diagnosis of HIV infection.
Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291899

Contacts

Contact: Shouki H Bazarbashi, MD
966505443546
bazarbashi@gmail.com
Locations

Saudi Arabia
king Faisal Specialist Hospital and Research Center
Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Shouki Bazarbashi, MBBS    966505443546    bazarbashi@gmail.com
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators

Principal Investigator:
Shouki Bazarbashi
King Faisal Specialist Hospital and Research cente
More Information
Publications:Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
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.

Responsible Party:
Shouki Bazarbashi, section Head,Medical oncology, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT03291899     History of Changes
Other Study ID Numbers:
RAC 2161 099

First Submitted:
September 21, 2017
First Posted:
September 25, 2017
Last Update Posted:
September 26, 2017
Last Verified:
September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No

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

Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Biliary Tract Cancers (FBI-TRAC)

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.

https://clinicaltrials.gov/ct2/show/NCT03291899

PurposeThis study is to evaluate the response rate and toxicity profile of infusional 5 fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFIRINOX) in first-line treatment of advanced biliary tract cancers and also to assess progression free survival and overall survival of FOLFIRINOX in first line treatment of advanced biliary tract cancers

Condition
Intervention
Phase
Biliary Tract Cancer
Combination Product: FOLFIRINOX
Phase 2

Study Type:
Interventional
Study Design:
Intervention Model: Single Group Assignment
Intervention Model Description:Simon 2-stage optimum design Model
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:
Phase II Trial of Infusional 5 FLUOROURACIL, LEUCOVORIN, OXALIPLATIN AND IRINOTECAN (FOLFIRINOX) in First Line Treatment of Advanced Biliary Tract Cancers

Resource links provided by NLM:

Drug Information available for: Fluorouracil Oxaliplatin Irinotecan
Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer
U.S. FDA Resources

Further study details as provided by Shouki Bazarbashi, King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:Response rate [ Time Frame: 3 year ]Evaluate the response rate using RECIST 1.1 criteria

Secondary Outcome Measures:progression free survival [ Time Frame: 4 years ]calculated from day 1 of chemotherapy till either progression, death or date of last follow up whichever comes first

overall survival [ Time Frame: 4 years ]calculated from day 1 of chemotherapy till either death or date of last follow up whichever comes first

Estimated Enrollment:
32
Actual Study Start Date:
January 3, 2017
Estimated Study Completion Date:
August 2020
Estimated Primary Completion Date:
August 2019 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Experimental: Experimental single armChemotherapy using the FOLFIRINOX regimen will be given every 2 weeks for a total of 12 cycles. FOLFIRINOX consist of:

Oxaliplatin-85 mg/m2 IV Day 1
Leucovorin-400 mg/m2 IV Day 1
Irinotecan-180 mg/m2 IV Day 1
Fluorouracil (FU)-400 mg/m2 IV bolus Day 1
Fluorouracil 2400 mg/m2 infused over 46 hours starting day 1
Combination Product: FOLFIRINOXcombination chemotherapy using Oxaliplatin, Irinotecan, Leucovorin and Fluorouracil, given every 15 days for a total of 12 cycles

Show Detailed Description

Eligibility
Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:
19 Years and older   (Adult, Senior)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Criteria
Inclusion Criteria:

Histologically confirmed locally advanced (irresectable) or metastatic biliary tract cancers.
Measurable disease. Defined as tumor that have uni or bi dimensional measurement not less than 1.5 cm on any dimension.
Age ≥ 18 years.
Signed written informed consent before enrolment.
No prior chemotherapy or anti-neoplastic therapy other than radiotherapy more than 4 weeks prior to enrolment and to areas other than the measurable disease.
Patients of either sex or child bearing age must be willing to use adequate contraceptive measures during the study and for 6 months after treatment.
Life expectancy of 6 months or more.
Eastern Cooperative Oncology Group performance status of 0-1.
Adequate renal function: creatinine within normal institutional range.
Adequate hepatic function: Total bilirubin within normal institutional limits, serum aspartate aminotransferase and alanine aminotransferase levels ≤2.5 times the institutional upper limit of normal or ≤ 5 times the institutional upper limit of normal of elevated because of liver involvement.
Adequate hematological values: leukocyte count ≥3.0 x 109/L, an absolute neutrophil count ≥1.5 x 109/L, a platelet count ≥100 x 109/L.
Exclusion Criteria:

Known or suspected dihydropyrimidine deficiency.
Presence of central nervous system metastasis.
Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer.
Severe cardiovascular disease (congestive heart failure New York Heart Association class three or four, unstable angina pectoris, myocardial infarction or significant arrhythmias).
Psychiatric or mental disorder, precluding understanding of the information of the trial related topics and giving valid informed consent.
Active uncontrolled infection.
Pregnant patients (confirmed by β-Human chorionic gonadotrophin test where appropriate).
Serious underlying medical condition (in the judgement of the investigator) which could impair the ability of the patient to participate in the trial.
Any psychological, familial, geographic or social circumstances which could impair the patient’s ability to participate in the trial and comply with follow up.
Treatment with other experimental drugs within 30 days of entry into the trial.
Treatment with other anti-cancer therapy.
Known hypersensitivity to any of the study drugs.
Breast feeding
Legal incapacity.
Patients with a known diagnosis of HIV infection.
Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291899

Contacts

Contact: Shouki H Bazarbashi, MD
966505443546
bazarbashi@gmail.com
Locations

Saudi Arabia
king Faisal Specialist Hospital and Research Center
Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Shouki Bazarbashi, MBBS    966505443546    bazarbashi@gmail.com
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators

Principal Investigator:
Shouki Bazarbashi
King Faisal Specialist Hospital and Research cente
More Information
Publications:Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
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.

Responsible Party:
Shouki Bazarbashi, section Head,Medical oncology, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT03291899     History of Changes
Other Study ID Numbers:
RAC 2161 099

First Submitted:
September 21, 2017
First Posted:
September 25, 2017
Last Update Posted:
September 26, 2017
Last Verified:
September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No

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

Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Biliary Tract Cancers (FBI-TRAC)

Currently recruiting.

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.

https://clinicaltrials.gov/ct2/show/NCT03291899

Purpose
This study is to Evaluate the response rate and toxicity profile of infusional 5 fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFIRINOX) in 1st line treatment of advanced biliary tract cancers and also To assess progression free survival and overall survival of FOLFIRINOX in first line treatment of advanced biliary tract cancers

Condition Intervention Phase
Biliary Tract Cancer
Combination Product: FOLFIRINOX
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Simon 2-stage optimum design Model
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Infusional 5 FLUOROURACIL, LEUCOVORIN, OXALIPLATIN AND IRINOTECAN (FOLFIRINOX) in First Line Treatment of Advanced Biliary Tract Cancers

Resource links provided by NLM:

Drug Information available for: Fluorouracil Oxaliplatin Irinotecan
Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer
U.S. FDA Resources

Further study details as provided by Shouki Bazarbashi, King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
Response rate [ Time Frame: 3 year ]
Evaluate the response rate using RECIST 1.1 criteria

Secondary Outcome Measures:
progression free survival [ Time Frame: 4 years ]
calculated from day 1 of chemotherapy till either progression, death or date of last follow up whichever comes first

overall survival [ Time Frame: 4 years ]
calculated from day 1 of chemotherapy till either death or date of last follow up whichever comes first

Estimated Enrollment: 32
Actual Study Start Date: January 3, 2017
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental single arm
Chemotherapy using the FOLFIRINOX regimen will be given every 2 weeks for a total of 12 cycles. FOLFIRINOX consist of:
Oxaliplatin-85 mg/m2 IV Day 1
Leucovorin-400 mg/m2 IV Day 1
Irinotecan-180 mg/m2 IV Day 1
Fluorouracil (FU)-400 mg/m2 IV bolus Day 1
Fluorouracil 2400 mg/m2 infused over 46 hours starting day 1
Combination Product: FOLFIRINOX
combination chemotherapy using Oxaliplatin, Irinotecan, Leucovorin and Fluorouracil, given every 15 days for a total of 12 cycles

Show Detailed Description

Eligibility
Information from the National Library of Medicine
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, Learn About Clinical Studies.

Ages Eligible for Study: 19 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
Histologically confirmed locally advanced (irresectable) or metastatic biliary tract cancers.
Measurable disease. Defined as tumor that have uni or bi dimensional measurement not less than 1.5 cm on any dimension.
Age ≥ 18 years.
Signed written informed consent before enrolment.
No prior chemotherapy or anti-neoplastic therapy other than radiotherapy more than 4 weeks prior to enrolment and to areas other than the measurable disease.
Patients of either sex or child bearing age must be willing to use adequate contraceptive measures during the study and for 6 months after treatment.
Life expectancy of 6 months or more.
Eastern Cooperative Oncology Group performance status of 0-1.
Adequate renal function: creatinine within normal institutional range.
Adequate hepatic function: Total bilirubin within normal institutional limits, serum AST and ALT levels ≤2.5 times the institutional upper limit of normal or ≤ 5 times the institutional upper limit of normal of elevated because of liver involvement.
Adequate hematological values: leukocyte count ≥3.0 x 109/L, an absolute neutrophil count ≥1.5 x 109/L, a platelet count ≥100 x 109/L.
Exclusion Criteria:
Known or suspected dihydropyrimidine deficiency.
Presence of CNS metastasis.
Previous malignancy within 5 years, except adequately treated non melanomatous skin cancer or in situ cervical cancer.
Severe cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction or significant arrhythmias).
Psychiatric or mental disorder, precluding understanding of the information of the trial related topics and giving valid informed consent.
Active uncontrolled infection.
Pregnant patients (confirmed by β-HCG test where appropriate).
Serious underlying medical condition (in the judgement of the investigator) which could impair the ability of the patient to participate in the trial.
Any psychological, familial, geographic or social circumstances which could impair the patient’s ability to participate in the trial and comply with follow up.
Treatment with other experimental drugs within 30 days of entry into the trial.
Treatment with other anti-cancer therapy.
Known hypersensitivity to any of the study drugs.
Breast feeding
Legal incapacity.
Patients with a known diagnosis of HIV infection.
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291899

Contacts
Contact: Shouki H Bazarbashi, MD 966505443546 bazarbashi@gmail.com

Locations
Saudi Arabia
king Faisal Specialist Hospital and Research Center Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Shouki Bazarbashi, MBBS 966505443546 bazarbashi@gmail.com
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Shouki Bazarbashi King Faisal Specialist Hospital and Research cente
More Information

Publications:
Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
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.

Responsible Party: Shouki Bazarbashi, section Head,Medical oncology, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT03291899 History of Changes
Other Study ID Numbers: RAC 2161 099
First Submitted: September 21, 2017
First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Unfortunately the full text is not available for free, but it’s a good overview of the research and developments thus far. Blessings, Tilly

Valle JW, Lamarca A, Goyal L, Barriuso J, Zhu AX.
New Horizons for Precision Medicine in Biliary Tract Cancers.
Cancer Discov. 2017 Aug 17. doi: 10.1158/2159-8290.CD-17-0245. [Epub ahead of print]
https://www.ncbi.nlm.nih.gov/pubmed/?term=28818953

Biliary tract cancers (BTC), including cholangiocarcinoma and gallbladder cancer,
are poor-prognosis and low-incidence cancers, although the incidence of
intrahepatic cholangiocarcinoma is rising. A minority of patients present with
resectable disease but relapse rates are high; benefit from adjuvant capecitabine
chemotherapy has been demonstrated. Cisplatin/gemcitabine combination
chemotherapy has emerged as the reference first-line treatment regimen; there is
no standard second-line therapy. Selected patients may be suitable for
liver-directed therapy (e.g., radioembolization or external beam radiation),
pending confirmation of benefit in randomized studies. Initial trials targeting
the epithelial growth factor receptor and angiogenesis pathways have failed to
deliver new treatments. Emerging data from next-generation sequencing analyses
have identified actionable mutations (e.g., FGFR fusion rearrangements and IDH1
and IDH2 mutations), with several targeted drugs entering clinical development
with encouraging results. The role of systemic therapies, including targeted
therapies and immunotherapy for BTC, is rapidly evolving and is the subject of
this review.Significance: The authors address genetic drivers and molecular
biology from a translational perspective, in an intent to offer a clear view of
the recent past, present, and future of BTC. The review describes a
state-of-the-art update of the current status and future directions of research
and therapy in advanced BTC. Cancer Discov; 7(9); 1-20. ©2017 AACR.

©2017 American Association for Cancer Research.

DOI: 10.1158/2159-8290.CD-17-0245
PMID: 28818953

Here is a link to an extensive list of patient teaching materials on chemotherapy drugs and chemotherapy supportive drugs from the University of Pittsburgh School of Health Sciences.

Common drugs given to cholangio patients can be searched here, i.e. Cisplatin, Gemcitabine (Gemzar), Megace (Megestrol), Dexamethasone (Decadron), Filgrastim, Epogen, Prednisone, Irinotecan, 5-Fu, Nivolumab, Pembrolizumab (Keytruda), 5HT3 antagonists (Kytril, Zofran, Aloxi), etc.

http://www.upmc.com/patients-visitors/education/cancer-chemo/Pages/default.aspx

This website is a wealth of information for patients and caregivers! Once you click on the above link, you may view any of the other patient teaching topic links found on the left of the linked website page. There is an entire section dedicated to gastrointestinal, radiation, nutrition and diet, pain control, and so on.

-Karen

Hello to everyone, I wanted to introduce myself and put up my first post. My 39 yo sister has been diagnosed with stage IV cholangiocarcinoma. It has been a nightmare for me and my family, everyday we are all walking around with heavy hearts and lumps in our throats. I should mention that I’m a physician, an internist, so I have first hand knowledge about how unfair and horrible this disease can be. My sister was doing great up until a few months ago in March when she started having mild abdominal pain. She has had Crohn’s and PSC for years, had been stable on meds for a long time. She lives in New York and went to NYU med for MRI in early April, which was read as “worsening PSC” but no discrete mass or dominant stricture, went for ERCP and had a stent placed. Pain and jaundice got a lot worse after that, she had another MRI done (3 weeks after the original) which showed 12 cm mass in the left liver with multiple lymph node and lung mets. She urgently underwent EUS with biopsy which confirmed the diagnosis of cholangiocarcinoma. She came back to Houston with me a few days later and I got her into MD Anderson a week later. She wasn’t able to start chemo right away unfortunately because her bilirubin was too high at ~18, so she was admitted to the hospital and had a biliary drain placed as well as a catheter to drain her ascites everyday. Bili was coming down and she went home, but I had to bring her back few days later due to an infection. Infection was treated and we got the bili down to ~7, her oncologist thought that was the best we were going to do and decided to finally start chemotherapy last week. She had her first round of gemcitabine/cisplatin on 6/27, she is scheduled for chemo every two weeks. Her oncologist is great, but I can certainly tell that he is not at all optimistic and has told me multiple times to not keep our hopes too high. She is recovering now, but unfortunately she is not doing well. Nutrition has been very difficult due to lack of appetite and discomfort, and even swallowing water is an difficult task. She has lost nearly all of her fat and muscle. She is so very weak and tired all day between the cancer, chemo, and multiple pain meds she requires. It is hard for her to keep her eyes open for more than a few minutes at a time. She is still staying strong and positive though, I’m so proud of her for doing her best to keep up with the things I make her do, like short walks and snacks every 1-2 hours. My wife and family are all wonderful, she is basically never alone and we are doing everything we can think of to fight this horrible monster. But I would be lying to say that my heart doesn’t ache everyday as I watch my wonderful, beautiful sister waste away. As a loving brother my attitude will always be stay strong and keep positive, but as a doctor I know that she is dying. I have seen so many great posts on this forum about everything and anything cholangiocarcinoma and it has been an invaluable resource. I appreciate any tips, treatment suggestions or any other forms of support that anyone has to give. Thank you for listening and I look forward to being a part of this family.

These are some citations to articles I discovered while searching PubMed and I wanted to share them with the community. Unfortunately the full texts of these articles aren’t available for free but at least the abstracts in PubMed have information. I hope I’m posting this in the right place. Moderators, please let me know if these should go elsewhere. Blessings!

Mitin T, Enestvedt CK, Jemal A, Sineshaw HM.
Limited Use of Adjuvant Therapy in Patients With Resected Gallbladder Cancer Despite a Strong Association With Survival.
J Natl Cancer Inst. 2017 Jul 1;109(7). doi: 10.1093/jnci/djw324.
PubMed PMID: 28376178.

https://www.ncbi.nlm.nih.gov/pubmed/28376178

Kim BJ, Hyung J, Yoo C, Kim KP, Park SJ, Lee SS, Park DH, Song TJ, Seo DW, Lee SK, Kim MH, Park JH, Cho H, Ryoo BY, Chang HM.
Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients.
Cancer Chemother Pharmacol. 2017 Jun 8. doi: 10.1007/s00280-017-3353-2. [Epub ahead of print]
PubMed PMID: 28597043.

https://www.ncbi.nlm.nih.gov/pubmed/28597043

Cho KM, Park H, Oh DY, Kim TY, Lee KH, Han SW, Im SA, Kim TY, Bang YJ.
Skeletal muscle depletion predicts survival of patients with advanced biliary tract cancer undergoing palliative chemotherapy.
Oncotarget. 2017 Jun 2. doi: 10.18632/oncotarget.18345. [Epub ahead of print]
PubMed PMID: 28621674.

https://www.ncbi.nlm.nih.gov/pubmed/28621674

Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients.

https://www.ncbi.nlm.nih.gov/pubmed/28597043

Grateful to have found this forum.

I wonder if anyone has faced a similar situation and if so, I would be keen to understand your experience and the advice you received.

My dad, 70, started Cisplatin/Gemcitabine last Dec for advanced CC. At that time the tumours had already spread to the lymph nodes. C/G (which has been taken for 6 months straight) managed to keep the tumours under control but a recent scan in May reveals that the tumours have grown. In any case his platelets were too low to continue on C/G.

His Drs says theres no standard line second-line treatment for Advanced CC, and has just started him on Oxaliplatin/Capecitabine (Xeloda). However, they say that the success rate (i.e. of keeping the tumours under control) is 10-20% and for most people it can only keep the tumours under control for 4-6 months. (I cannot find online literature to verify this)

If this fails, he can only try experimental treatments but this would depend on eligibility to join and platelets will most likely be the limiting factor.

Does anyone have experience with Oxaliplatin/Capecitabine as second line and what has the experience been? Did the Drs quote similar numbers?

Drs say 6 – 12 months from this point. Not sure what to make of this.

Thanks so much in advance.