Search Results for 'gemcitabine cisplatin'
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Search Results
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NCCN Chemotherapy Order Templates (NCCN Templates®)
Hepatobiliary Cancers – Intrahepatic CholangiocarcinomaResectable, Unresectable, or Metastatic
HEP17: Capecitabine
HEP13: Capecitabine/CISplatin
HEP14: Capecitabine/OXALIplatin
HEP18: Fluorouracil
HEP2: Gemcitabine
HEP12: Gemcitabine/Capecitabine
HEP10: Gemcitabine/CISplatinResectable or Unresectable
HEP19: Capecitabine with Radiation
HEP7: Fluorouracil with RadiationNCCN Templates Appendix A: Calculations, Assumptions, Clearances
NCCN Templates Appendix B: Calvert Equation
NCCN Templates Appendix C: Growth Factors
NCCN Templates Appendix
Nausea/Vomiting
NCCN Templates Appendix E: Regimen References
NCCN Templates Tall Man LetteringThe NCCN Guidelines are a statement of consensus of the authors regarding their views of currently accepted approaches to cancer treatment. The recommendations regarding the uses and indications in the NCCN Compendium have been derived directly from the NCCN Guidelines. The NCCN Compendium represents neither an all-inclusive listing of every drug and biologic nor every appropriate use and indication for drugs and biologics. The NCCN Templates are peer reviewed statements of consensus of their authors derived from the NCCN Guidelines for the conditions the NCCN Templates address. The NCCN Templates are not exhaustive and do not represent the full spectrum of care or treatment options described in the NCCN Guidelines or the NCCN Compendium or include all appropriate approaches or combinations of drugs or biologics for the treatment of cancer. A NCCN Template does not constitute an order
[Surgical Resection after Gemcitabine plus Cisplatin Chemotherapy for Intrahepatic Cholangiocarcinoma with Multiple Lymph Node Metastases – Report of a Case].
In reply to: My Mum, 49yo in Australia
Hi everybody, thought I would just let you know that we are having some positive response to the gemcitabine/cisplatin, with the first scan showing shrinkage and no spreading! We were quite happy to hear. We are still yet to get an opinion from the other surgeon, we will likely see him once mum has ridden out the rest of the gem/cis. So we are not sure where to go next after this chemo.
She seems to be tolerating it okay, main issues are neutropenia and low platelet counts which have caused chemo to be delayed a couple of times. One time I pushed the oncologist for a few days of filgrastim, which was times well as she managed to catch a cold that thankfully didn’t progress into anything worse. She’s also had some mild cellulitis on her face which I caught on early to and ensured it was treated with antibiotics.
Besides that, she’s having some problems with pain in the bowels, which gets worse after chemo. Likely due to mucositis.
In reply to: Survival…Please tell us your latest milestone
Here is a “What’s Working” update. My wife, Barb, was found to have cancer in late July 2016. Through the process of elimination or exclusion, the various docs concluded it was ICC.
As I have mentioned earlier, she was offered to join a phase II clinical trial at Moffitt Cancer Center in Tampa Bay with Dr Richard Kim and team. We started early Sept. Barb’s tumors were ‘too numerous to count’ in the liver and lung primarily. They are measuring a couple of the larger ones to track progress – and here is that progress…Date 8/23/16 11/15/16 1/17/17
Confluent central mass 7.5 x 12.6 6.2 x 9.9 5.9 x 8.4
Right hepatic lobe mass 4.9 x 6.4 4.4 x 4.9 3.0 x 4.2
The trial drug is Copanlisib (BAY 80-6946) and the chemo drugs are Cisplatin and Gemcitabine. The Protocol number for this trial is MCC # 18435
More at https://clinicaltrials.gov/ct2/show/NCT02631590?term=mcc+18435&rank=1Barb also has added supplements such as Kyogreen drink mix and several other things AND is doing one or two coffee enemas every day. This is not part of the trial protocol as you might imagine but we believe it is part of the good results she is getting. Would love to hear any feedback, thoughts, comments. God bless you! Brian
Here are the long awaited results of PRODIGY 12-ACCORD 18 , Clinical Trial, conducted in France:
Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery
https://clinicaltrials.gov/show/NCT01313377Results: THERE WAS NO SIGNIFICANT, STATISTICALLY DIFFERENCE IN SURVIVAL FOR PATIENT TREATED WITH GEM/OX FOLLOWING RESECTION.
Adjuvant therapy achieved 30 month vs. 22 month of untreated patients.
“In the PRODIGE 12 trial we showed that adjuvant GEMOX was feasible and toxicities were as expected without any detrimental effect on global quality of life,” said Julien Edeline, MD, of Oncology Medical Eugene Marquis Comprehensive Cancer Center, Rennes, France. “However, adjuvant GEMOX was not associated with an improvement in recurrence-free survival.”
READ MORE:
http://www.cancernetwork.com/asco-2017-gastrointestinal-cancers-symposium/adjuvant-gemox-did-not-improve-rfs-localized-biliary-tract-cancer%20?GUID=F0B4FECE-59A0-4A23-99C1-DA933C290DEA&XGUID=&rememberme=1&ts=24012017Next we are awaiting the outcome the
BilCap Study:
Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer
https://clinicaltrials.gov/ct2/show/NCT00363584
The results will be presented at the upcoming ASCO 2017, ChicagoWe don’t expect to receive data of The Attica 1 study for some time to come:
Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Observation After Curative Intent Resection of Biliary Tract Cancer (ACTICCA-1)
https://clinicaltrials.gov/ct2/show/NCT02170090#sthash.3uhj5Fxw.dpufIt may be beneficial to speak with your physician about chemotherapy following your resection with
R0 – no cancerous cells seen microscopically; this is the desired result
R1 – cancerous cells can be seen microscopicallyHugs
MarionIn reply to: Oncologists Opinions: How many did you see?
positivity…..I hope that other share in and answer your questions regarding how may opinions and what treatment chosen.
The way I see it, SIRT is mentioned by all three specialist.
1. prefers to address the anemia prior to application of chemo. He did not mention the protocol, but SIRT would be included.
2. SIRT and Xeloda. This specialist is taking the stance that taking on the cancer and addressing the anemia with blood transfusions , if indeed your Mom can’t tolerate the treatment.
3. Gemcitabine/Cisplatin and possible SIRT. This specialist prefers to address the cancer with the most used treatment protocol, while leaving open the option of SIRT thereafter.
As there is no standard of treatment for this cancer, physicians choose the best available option for their patients, based on their experience.
Hugs
MarionJapan – Not Yet Open.
A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer
https://clinicaltrials.gov/ct2/show/NCT03027284
Purpose
The main purpose of this study is to evaluate tolerability of merestinib monotherapy or in combination with other anti-cancer agents in Japanese participants with advanced and/or metastatic cancer.Condition Intervention Phase
Advanced Cancer
Metastatic Cancer
Biliary Tract Carcinoma
Cholangiocarcinoma
Gall Bladder Carcinoma
Solid Tumor
Non-Hodgkin’s Lymphoma
Drug: Merestinib
Drug: Cisplatin
Drug: Gemcitabine
Phase 1Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I Study of Merestinib Monotherapy or in Combination With Other Anti-Cancer Agents in Japanese Patients With Advanced and/or Metastatic CancerResource links provided by NLM:
Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride
Genetic and Rare Diseases Information Center resources: Lymphosarcoma Gallbladder Cancer
U.S. FDA ResourcesFurther study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
Number of Participants with Merestinib Dose-Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (Part A = 28 Days or Part B = 21 Days) ]Secondary Outcome Measures:
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Merestinib and its Metabolites [ Time Frame: Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles) ]
PK: Area Under the Concentration Time Curve (AUC) of Merestinib and its Metabolites [ Time Frame: Predose Cycle 1 Throughout the First 2 Cycles (Part A = 28-Day Cycles, Part B = 21-Day Cycles) ]
Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months) ]
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated as up to 8 Months) ]Estimated Enrollment: 18
Study Start Date: January 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Merestinib (Part A Dose Level 1)
Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
Drug: Merestinib
Administered orally
Other Name: LY2801653
Experimental: Merestinib (Part A Dose Level 2)
Merestinib administered orally. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
Drug: Merestinib
Administered orally
Other Name: LY2801653
Experimental: Merestinib + Cisplatin + Gemcitabine (Part
Merestinib administered orally with cisplatin and gemcitabine administered intravenously (IV). Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met, but Cisplatin and gemcitabine treatment will be limited to a maximum of 8 cycles.
Drug: Merestinib
Administered orally
Other Name: LY2801653
Drug: Cisplatin
Administered IV
Drug: Gemcitabine
Administered IV
Other Name: LY188011Eligibility
Ages Eligible for Study: 20 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:Part A: Histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (solid tumors or non-Hodgkin’s lymphoma).
Part B: Biliary tract carcinoma that is unresectable, recurrent, or metastatic. The participant must not have received prior systemic front-line therapy for metastatic or resectable disease.
Part A: Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Cheson Criteria.
Part B: Measurable disease as defined by RECIST v1.1.
Adequate organ function including hematologic, hepatic and renal.
Eastern Cooperative Oncology Group (ECOG) scale of 0 or 1.
Are able to swallow tablets.
For participants in Part B, a tumor tissue sample is mandatory for biomarker analysis.
Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug.
Females with childbearing potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug.
A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, breastfeeding must cease from the day of the first study drug administration until at least 3 months after the last administration.
Exclusion Criteria:Have serious pre-existing medical conditions.
Have a chronic underlying infection.
Have symptomatic central nervous system malignancy or metastasis.
Have an active fungal, bacterial, and/or known viral infection.
Part B: Have mixed hepatocellular biliary tract carcinoma histology.
Have liver cirrhosis with a Child-Pugh stage of B or higher, or have received a liver transplant.
Have a history of congestive heart failure with New York Heart Association (NYHA) class greater than 2, unstable angina, or have recent history of myocardial infarction, transient ischemic attacks, stroke, or arterial or venous vascular disease.
Have a corrected QT interval >470 milliseconds as calculated be the Fredericia equation.
Have a second primary malignancy that, in the judgment of the investigator, and sponsor may affect the interpretation of results.
Have any evidence of clinically active interstitial lung disease (ILD).
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: NCT03027284
Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5 hours, EST) Eli Lilly and Company
More InformationResponsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03027284 History of Changes
Other Study ID Numbers: 16330 I3O-JE-JSBG
Study First Received: January 19, 2017
Last Updated: January 19, 2017Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: NoIn reply to: What do you think about your Chemo Protocol
Alikemal,
I should preface this post with the understanding that although a study may come out with a chemotherapy regimen for a specific cancer, there is much room for interpretation. Every oncologist will order differently, and this is not something that I can expound on as I am an oncology nurse. Hospitals also develop their own protocols.
In looking through the chemotherapy orders (or your very organized sheet!) what I see first is the protocol. This protocol appears to be roughly following the standard of care for biliary cancer based off the ABC-02 trial from 2010. Now I will go through the whole order sheet. I will attach the links to the New England Journal of Medicine (NEJM) where the ABC-02 study was published, and also Cancer Therapy Advisor so you may see where I sourced this information for you.1. The orders state that the chemotherapy administration will be on 1 and 8, every 21 days. (This would be one “cycle”). The ABC-02 trial was to give gemcitabine/cisplatin on days 1 and 8 every 3 weeks (so roughly 21 days). This treatment is to be given in 4 cycles per the study.
2. The order sheet says Cisplatin 30 mg/m2 and Gemcitabine 1000 mg/m2. The ABC-02 study and the Cancer Therapy Advisor list the doses as Cisplatin 25 mg/m2 and Gemcitabine 1000 mg/m2. Why the slight difference for your order sheet? Perhaps this is a case where the oncologist is ordering based on their knowledge base. You could always ask.
3. Numbers 5 and 6 in the list on the order sheet- Cisplatin 40 mg- The cisplatin orders state that this dose is to be 30 mg/m2. BSA is 1.48/m2 so 30mg x 1.48= 44.4 mg. Whoever mixed the chemo did 40 mg of Cisplatin even though the dose is technically 44.4. They chose to round down which I will explain in a bit. Gemcitabine 1000 mg/m2. 1.48 x 1000 = 1,480 mg. The given dose though is 1100 mg. Here again, the dose was decreased.
4. Numbers 1, 2, 3, 4. 1. Dekort I believe must be Decadron, a steroid and a pre-medication to prevent adverse reactions from the chemotherapy. 16 mg looks right to me. 2. My facility happens to give Ondansetron (Zofran) at 8 mg to prevent nausea (another premedication) 3. Benison or Avil, I have not heard of. As it says “antihistamine” on the sheet, I’m guessing this must be something like Benadryl, which I have given as a premedication for many things, including chemotherapy. I cannot remember giving this before Gemcitabine/Cisplatin, but I’m not saying this is wrong for it to be given. 4. Lasix 20 mg. Lasix (Furosemide) is a diuretic to help the body to diurese. The 1000 ml of saline is a kidney protectant as the Cisplatin is toxic to the kidneys. I have not given Lasix with Cisplatin before, but I certainly have pre and post hydrated with saline. Again, this must be oncologist specific per their knowledge base.
5. Number 7, Emend. This medication is an NK-1 antagonist, or a heavy duty anti-nausea medication that has been shown in studies to work very well to fight the kind of nausea that can occur with Cisplatin, which can be very severe. Cisplatin is what we call a “highly emetogenic” chemotherapy so precautions such as the administration of Emend will help to ward off this nausea/vomiting.
Now I will explain about dose reduction and speculate on why the entire 1-7 were given the first time, and not the second. Dose reduction is done for the safety of the patient. Your mother is 70, and perhaps she has some other illnesses (diabetes, heart disease, etc.). She may have underlying kidney or liver function issues…I do not know what her lab work would reveal or her health history. Oncologists will dose reduce to treat, but do as little harm to the body, which I suspect happened in this case. This is again why your mother most likely received Gemcitabine alone without the Cisplatin. Cisplatin can be especially harsh and cause the kidneys to struggle, and greatly affect the bone marrow and resultant lab results. (Platelet count can drop markedly, as well as the white blood cell count (WBC), hemoglobin/hematocrit, neutrophils, etc.). Neuropathy can occur too with the Cisplatin, and this will cause an oncologist to dose reduce or discontinue.
My advice would be to ask the oncologist any questions you may have, and look through the resources that I provide links for. Again, every oncologist orders differently and the information I have provided is my opinion based on experience, but I am not a physician.
Hopefully this will ease your mind, as it appears that the orders are very similar to the current standard of care treatment with some minor changes.-Karen D.
http://www.nejm.org/doi/full/10.1056/NEJMoa0908721#t=articleDiscussion
Topic: Stomach pain and nausea
Hi everyone, I just want to say thank you for all the help and advice the site has given me over the last few months.
My husband who is 55 was diagnosed with cholangiocarcinoma in the middle of last year. He was an outgoing person, a fixer and a problem solver, and this horrible disease has changed all that. We have 3 grown up children, a granddaughter and another grandchild due in the middle of march.My husband was admitted to Hospital in early April 2016 due to severe jaundice. He had an ultrasound scan, which showed a significant build-up of ‘sludge’ in the Gall Bladder and the possible presence of gall stones, he was kept in hospital put on and IV and nil buy mouth. His gall bladder was removed shortly after. During the operation to remove the Gall Bladder, the surgeon found it very difficult to unblock the common bile duct, due to suspected gall stones. A hole was forcefully created through the obstruction and a stent was inserted to allow the normal flow of bile.
Around three weeks after being discharged he developed jaundice again during a trip to France and was re-admitted to Hospital where he underwent an emergency ERCP, where the original stent was removed and a smaller metal stent was inserted. During the ERCP the doctor in charge of the procedure noted a collection of abnormal cells. A sample of these cells was sent for a histologic examination. His discharge note read ” possible malignant tumour” although this had never been discussed with us previously. The cells were later confirmed as adenocarcinoma cells.
We were assured at this time that the tumour was easily operable, as it was only small ( around 2 cm), subsequently, he was admitted on 6th June 2016 for the whipple operation.
At the time of the surgery, it was unfortunately noted that there were threads of the tumour on peritoneum was and the surgery would not offer any benefit. Accordingly, a palliative double biliary and gastric bypass was undertaken. He was discharged on 15th June 2016 and referred to Oncology at The Christie in Manchester, to proceed with treatment.
Initially my husand was referred to the Christie Hospital on the NHS. At the first consultation a junior Dr informed us that without treatment he had 3-6 months to live, with treatment 6-12. We were told there were no trials available, and we felt utterly helpless. We have private medical cover and so transferred to the private wing at The Christie. He had a consultation on Monday 11th July and, a CT scan on Tuesday 12th July and commenced chemotherapy treatment (gemcitabine and cisplatin) on Wednesday 13th July.
Treatment initially proved successful at the 3 month review, with a reduction in his tumour markers to 99 from 680 and the first CT scan showing a reduction in lymph node size ( we were not previously aware that the cancer had spread to this area).
Unfortunately towards the end of the second round of chemotherapy my husband became unwell as tests proved he had contracted sepsis. He was in severe pain and, as a result of the nausea he was suffering, became unable to eat. He was taken into the Christie hospital on the 25th of November where he was treated and released almost a week later. A CT scan was carried out during this period and the lymph nodes appeared to be back normal size.
My husband was due to finish Chemotherapy on the 14th of December, however due to his symptoms, his last dose was on the 7th of December 2016. He continued to be in great pain in the weeks following his last dose, he was struggling to eat and spent much time in bed. On the 27th of December he was readmitted to the Christie Hospital, and on the 29th of December had a second CT scan and blood tests. The results showed tumour markers of 116 and the scan revealed subtle growth in the main tumour and inflamed lymph nodes this was presumed to be the cause of my husbands discomfort.
At a consultation on the 30th of December we were told my husband was now resistant to the gemcitabine & cisplatin and that, the current method of chemotherapy would no longer be effective. We have a consultation on Wednesday to discuss further treatment options.
We are currently managing his pain along with the help of the pain management team at the hospital. He is on a mixture of painkillers including metaclopromide and amytriptyline. Control is very hit and miss, and we think that trapped wind is contributing to his discomfort; he has bad flatulence and his stomach gripes often. The pain management team are wanting to prescribe more medication however, we feel if this is the cause of the pain, it needs addressing.
Has anyone had any experience of this and found a solution? Any help would be greatly appreciated.Thank you for reading war and peace, looking forward to hearing some constructive comments.
Bev
@ Marion Sorry for my late response, things have been quite hectical lately. Procedures like radiofrequency ablation, cryoablation and radioembolization aren’t done here for cholangiocarcinoma because they haven’t been proven successful enough. Although healthcare in the Netherlands has been proven the best in Europe in a recent study by HCP, I sometimes wish it was a little less conservative.
Yesterday my father heard the results from the new scan – in 6 weeks time the lesions in his liver have doubled in size. Although six weeks ago the hospital told us he might still have a year, now they have adjusted it to a few months due to the rapid growth. Next week we will have an appointment in another academic hospital about a targeted therapy trial. I so hope he can still participate in this one. He finished the Acticca-1 study (gemcitabine and cisplatin) wih absolutely no results except for being really ill and reccurence within a week after finishing the trial.
Topic: Elevated Lipase
My wife, Barb, is part of a clinical trial at Moffitt Cancer Center. Started in Sept and is going pretty well. Gemcitabine and cisplatin with coplanlisib (trial drug)
Today her Lipase count was very high – at 265. Has been around 40 for months. I have read some articles including http://www.webmd.com/digestive-disorders/lipase-14225#2
Anyone have any experience like this? Brian
A Trial of Systemic Chemotherapy in Combination With Conventional Transarterial Chemoembolization in Patients With Advanced Intra-Hepatic Cholangiocarcinoma
Yale University. Not open yet.
Purpose
The study will be a single-center, single-arm, Phase II study of gemcitabine and cisplatin in combination with conventional trans-arterial chemoembolization therapy in adult patients with advanced ICC. 25 patients will be enrolled over the course of 2 years, with an additional 1.5 years for patient follow-up.Condition Intervention Phase
Unresectable Intrahepatic Cholangiocarcinoma
Drug: gemcitabine
Drug: Cisplatin
Drug: Conventional TACE (transarterial chemoembolization) with Doxorubicin/Mitomycin-C
Phase 2Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Systemic Chemotherapy (Gemcitabine and Cisplatin) in Combination With Conventional Transarterial Chemoembolization (cTACE) in Patients With Advanced Intra-Hepatic Cholangiocarcinoma (ICC)Resource links provided by NLM:
Genetics Home Reference related topics: cholangiocarcinoma
Drug Information available for: Gemcitabine
Genetic and Rare Diseases Information Center resources: Intrahepatic Cholangiocarcinoma
U.S. FDA ResourcesFurther study details as provided by Yale University:
Primary Outcome Measures:
progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
The primary objective of this study is to evaluate the 12-month progression-free survival (PFS) rate in adult patients with intrahepatic cholangiocarcinoma (ICC) after treatment with gemcitabine and cisplatin in combination with conventional TACE. This is the percentage of patients alive and free of progression at 12-months from enrollment on study. Radiographic assessment of disease burden will be evaluated by mRECIST and qEASL using an MRI scan obtained at the IR clinic visit.Secondary Outcome Measures:
overall survival [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Evaluation of overall survival (OS) of adult patients with advanced ICC treated with gemcitabine and cisplatin in combination with conventional TACE. Overall survival is the time from enrollment on study until death of the patient from any cause.overall time to progression (TTP) [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
Overall TTP is the time from enrollment on study until radiographic evidence of overall disease progression. Radiographic assessment will be evaluated by mRECIST using MRI every 2 cycles after intra-arterial therapy.time to untreatable progression (TTUP) [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
TTUP in liver lesions is measured from the time of initiation on cTACE therapy until radiographic evidence of disease progression in targeted lesions. Radiographic assessment will be evaluated by mRECIST using MRI every 2 cycles after intra-arterial therapy.toxicities of the gemcitabine and cisplatin regimen in combination with cTACE therapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
To evaluate the toxicities of the gemcitabine and cisplatin regimen in combination with cTACE therapy in adult patients with advanced ICC. Safety will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.correlation between changes in dynamic contrast-enhanced MRI of liver lesions and progression free survival [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
early changes in dynamic contrast-enhanced MRI (DCE-MRI) will correlate with long term PFS or OS, specifically as they relate to lesions targeted with cTACE therapycorrelation between changes in dynamic contrast-enhanced MRI of liver lesions and overall survival [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
early changes in dynamic contrast-enhanced MRI (DCE-MRI) will correlate with long term OS, specifically as they relate to lesions targeted with cTACE therapyEstimated Enrollment: 25
Study Start Date: December 2016
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All subjects
Patients must have advanced, unresectable intrahepatic cholangiocarcinoma (ICC) defined as biopsy-confirmed adenocarcinoma in the liver, with an immunohistochemical profile consistent with a pancreatico-biliary primary, not involving the common bile duct or bifurcation, and not amenable to surgical resection.
Drug: gemcitabine
1000 mg/m^2 of gemcitabine on Day 1 and 8, Dosages may be modified or delayed due to toxicities
Drug: Cisplatin
25 mg/m^2 on Day 1 and 8, Dosages may be modified or delayed due to toxicities
Drug: Conventional TACE (transarterial chemoembolization) with Doxorubicin/Mitomycin-C
If conventional transarterial chemoembolization (TACE) is warranted based on MRI assessment and the patient meets all the eligibility criteria for TACE therapy, then cTACE will be scheduled to take place during Week 3 of that cycle. Patients will always receive the first cTACE for study; follow-up cTACE will occur on demand.Detailed Description:
Eligible patients enrolled on study will receive a chemotherapy regimen of gemcitabine and cisplatin administered intravenously on Days 1 and 8 of a 21-day cycle. After every 2 cycles of systemic chemotherapy, patients will receive contrast-enhanced MRI to assess liver disease; conventional trans-arterial chemoembolization (TACE) will be performed as indicated based on this assessment. Patients will receive a maximum of 8 cycles of the gemcitabine/cisplatin combination. Up to 3 TACE treatments may be delivered in this same time frame, with the first TACE taking place after 2 cycles of systemic chemotherapy. Following the treatment period, patients will continue clinical follow-up at 3 month intervals until study exit at 18 months post the start of treatment.It is hypothesized that the addition of conventional transarterial chemoembolization to standard chemotherapy will result in an improvement in PFS in patients with advanced, unresectable ICC, including patients with extra-hepatic disease.
Eligibility
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:Patient is at least 18 years of age.
Patient has advanced, unresectable intrahepatic cholangiocarcinoma (ICC). Advanced, unresectable ICC is defined as biopsy-confirmed adenocarcinoma in the liver, with an immunohistochemical profile consistent with a pancreatico-biliary primary, not involving the common bile duct or bifurcation, and not amenable to surgical resection.
Eligible for conventional TACE as defined by local treatment guidelines.
Child-Pugh class of A to B7.
Adequate end-organ and bone marrow function as manifested as:
Hemoglobin ≥ 9 g/dL
Absolute neutrophil count ≥ 1500/mm3
Creatinine ≤ 2.0 g/dL
AST and ALT ≤ 5 x ULN
Albumin ≥ 2.4 mg/dL
Total bilirubin ≤ 2.5 mg/dL
Platelets ≥ 100,000/mm3
For TACE procedures, subjects are allowed to have platelets ≥ 75,000/mm3.
Disease is liver-dominant with >70% of measurable disease burden within the hepatic parenchyma.
No prior surgery or chemotherapy for ICC.
ECOG performance status of 0-1.
No other active malignancy within 2 years.
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study.
Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:Prior or concurrent chemotherapy treatment for advanced ICC.
History of allergic reactions attributed to compounds of similar chemical or biological composition to gemcitabine, cisplatin, doxorubicin, or mitomycin-C.
Active treatment with CYP3A4 strong inhibitors or inducers.
Recent surgical procedure within 21 days of study enrollment.
Severe and/or uncontrolled co-morbid medical conditions including, but not limited to, active infection, viral hepatitis, congestive heart failure, cardiac arrhythmia, unstable angina pectoris, and psychiatric illness or social circumstance that would limit compliance with study requirements.
Pregnancy during study duration.
Active immunosuppressive medications.
Presence of grade 2 or higher hepatic encephalopathy.
Complete occlusion of the entire portal venous system. Partial or branch portal vein occlusion allowed if without reversal of flow.
Radiotherapy within 21 days from treatment with study interventions or medications.
Current, recent (within 4 weeks of first infusion of this study), or planned participation in additional experimental drug.
Unstable angina.
New York Heart Association (NYHA) Grade II or greater congestive heart failure (Appendix C).
History of myocardial infarction or CVA within 6 months prior to study enrollment.
Clinically significant peripheral vascular disease.
Inability to comply with study and/or follow-up procedures.
Life expectancy of less than 12 weeks.
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: NCT02994251
Contacts
Contact: Jean-Francois (Jeff) Geschwind, MD +1 (203) 785-5865 jeff.geschwind@yale.edu
Contact: Eliot Funai (203) 785-4246 eliot.funai@yale.eduLocations
United States, Connecticut
Smilow Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
Contact: Jeff Geschwind, MD 203-785-5865 jeff.geschwind@yale.edu
Sub-Investigator: Hyun Kim, MD
Sub-Investigator: Stacey Stein, MD
Sub-Investigator: Howard S Hochster, MD
Sub-Investigator: Todd Schlachter, MD
Sub-Investigator: Jill Lacy, MD
Sub-Investigator: Jeffrey Pollak, MD
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Jean-Francois (Jeff) Geschwind Yale University
More InformationResponsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02994251 History of Changes
Other Study ID Numbers: 1603017367
Study First Received: December 6, 2016
Last Updated: December 14, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review BoardAdditional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Doxorubicin
Mitomycins
Mitomycin
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
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Alkylating Agents
Nucleic Acid Synthesis InhibitorsClinicalTrials.gov processed this record on December 16, 2016
In reply to: My Mum, 49yo in Australia
Mum started her Gemcitabine/Cisplatin chemotherapy last week. First week was tolerated well. Some mild nausea, but beside that her energy levels have been okay and no other symptoms so far. She went today to have her second dose as part of cycle 1, however her platelets came back at 50 x 10^9/L (it was at 90 before her first dose of chemo) and they said they had to delay. They will try and do the chemo in a weeks time if her platelets are okay. Her localised liver pain has eased since chemo and her shoulder nerve pain has been near non existent which the oncologist saw as a positive sign.
We finally got all the referrals sorted to see the surgeon in Sydney so hopefully we can go see him soon also.
In reply to: We are a team and must fight together
Hi Bob,
Boy, do I identify with you when you say your life tipped over like an apple cart when you found out you had cc. The very same goes for my husband. He was diagnosed in early July of this year and had a resection of the main bile duct in early August. The thought never, ever entered either of our minds that his five day stomach ache would turn into such a nightmare. The good news is that he could have the resection and for that we are thankful. But boy oh boy, were we ever taken by surprise and life as we knew it has really changed.
It sounds like you are in good hands at UNC Chapel Hill and that you have a plan in place. It’s so important to feel confident in your team and you seem to voice that.
My husband has had once cycle of Gemcitabine and Cisplatin and will begin his second cycle this Wednesday. It’s so fortunate that he has had few side effects from it other than fatigue. His appetite is really good and there has been no nausea either. However, we have been told that as the cycles progress that the other side effects may surface or the fatigue worsen. We take it one day at a time, or at least we try to do that. I tend to be over protective and he tends to act like there’s nothing wrong! I suspect this is common behavior among couples!
We send our prayers out to you and your family. I feel confident that you will do well with your chemo treatment. Just remember that you are not alone in this struggle for we all are here to vent or inquire or learn. Be positive and feel us rooting for you! Keep us posted, will you?
Red
Hi, I’m Bob Fisher in Cary NC. Like many of you, My whole apple cart (LIFE) turned over a couple of weeks ago, after finding out I have CC. I’m being treated at UNC Hospital at Chapel Hill NC. My tumor in the liver is approximately 8 cm. After 1 MRI and 3 cat scans it appears the cancer is still in the liver. They are not able to resection yet because it is close to the major vein, But hope to use chemo to reduce the size of the tumor and then they might be able to perform surgery. I start chemo next Thursday. They are starting me on Gemcitabine and Cisplatin. Anyone know anything about this combination. Any success in reducing the size? This site is a blessing and I have read and read. Thank all of you for your posts, They helped! I’m very interested in the treatment of using my stem cells (T cells), But the doctor says insurance does not cover this cancer yet. I saw one post on that treatment. Anyone know more about that treatment?I have found that eating something small every two hours helps me. Prayers help more than anything. My prayers are with you and your families each day.
