A Study to See the Effects That a New Combination of the Three Drugs, Nab-paclitaxel, Gemcitabine, and Cisplatin Has on Biliary Tract Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02632305|
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : March 14, 2018
You are being asked to take part in this study because you have a biliary cancer that is incurable and has spread to other organs. Chemotherapy is often used to help shrink the cancer temporarily and may improve survival. In Canada, the combination of gemcitabine and cisplatin is the chemotherapy combination used to treat biliary cancer that has spread. There is no other known treatment for biliary cancer that has spread to other organs. It is hoped that this new combination of drugs (nab-paclitaxel, gemcitabine, and cisplatin) will improve the tumor shrinkage rate.
This study is being done because we do not know whether 2 or 3 chemotherapy drugs is better to treat biliary cancers.
We hope to learn whether giving nab-paclitaxel, gemcitabine, and cisplatin together in patients with biliary cancer can increase tumor shrinkage without too many side effects.
The purpose of this study is to find out what effects (good and bad) nab-paclitaxel, gemcitabine, and cisplatin has on you and your biliary cancer.
|Condition or disease||Intervention/treatment||Phase|
|Unresectable Biliary Tract Cancer||Drug: nab-paclitaxel in combination with gemcitabine + cisplatin||Phase 2|
There is increasing evidence that there is a large degree of pathologic homology between the pancreas and biliary tract. Indeed, the biliary tract has been referred to as "an incomplete pancreas" and embryologically the two originate from the same structure. It is thus plausible that oncogenesis in the pancreas and biliary tract are related and that pancreas and biliary cancers have reciprocal effective treatment strategies.
To date, the only chemotherapeutic agents effective in advanced biliary tract tumors is the combination of gemcitabine and cisplatin. Known and approved therapies for advanced pancreas cancer include single agent gemcitabine, the four drug combination of FOLFIRINOX (5-fluorouracil, leucovorin, oxaliplatin, and irinotecan), the questionable limited benefit of inhibiting the epidermal growth factor receptor pathway, and most recently the combination of gemcitabine and nab-paclitaxel.
Based on promising results in pancreas cancer, investigators hypothesize nab-paclitaxel in combination with gemcitabine + cisplatin will be an effective cytotoxic combination in BTC treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre, Open-label Phase II Study of Nab-paclitaxel in Combination With Gemcitabine + Cisplatin as First Line Treatment in Patients With Unresectable Biliary Tract Cancer|
|Actual Study Start Date :||July 13, 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||June 2020|
Eligible patients will receive nab-paclitaxel in combination with gemcitabine + cisplatin at the recommended phase II dose based on the phase I study completed in metastatic pancreas cancer patients.
The doses of study drugs will be as follows:
Nab-paclitaxel will be administered first followed by cisplatin and then gemcitabine on day 1 and 8 of each treatment cycle. Cycles will be 3 weeks in length (21 days).
Drug: nab-paclitaxel in combination with gemcitabine + cisplatin
Patients with unresectable BTC will be treated with the triple combination of nab-paclitaxel in combination with gemcitabine + cisplatin
- Overall response rates [ Time Frame: 1 year ]defined as the sum of complete response rates and partial response rates, of nab-paclitaxel in combination with gemcitabine + cisplatin in first line treatment of unresectable biliary tract cancer (BTC).
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): NCT02632305
|Contact: Jennifer Spratlin, MD FRCPC||780-432-8513||Jennifer.Spratlin@albertahealthservices.ca|
|Contact: Michael Sawyer, MD FRCPC||780-432-8248||Michael.Sawyer@albertahealthservices.ca|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada|
|Contact: Jennifer Spratlin, MD FRCPC Jennifer.Spratlin@albertahealthservices.ca|
|Principal Investigator:||Jennifer Spratlin, MD FRCPC||Alberta Health Services|