NCT02632305

A Study to See the Effects That a New Combination of the Three Drugs, Nab-paclitaxel, Gemcitabine, and Cisplatin Has on Biliary Tract Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Unresectable Biliary Tract Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-07-13
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2015-12-16
• Last updated: 2025-06-26

Locations

2 sites across 1 country: Canada