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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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<

Brief Summary:

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.

Detailed Summary:
Sponsor: AHS Cancer Control Alberta

Current Primary Outcome: Overall response rates [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: AHS Cancer Control Alberta

Dates:
Date Received: December 14, 2015
Date Started: July 2016
Date Completion: January 2019
Last Updated: February 1, 2017
Last Verified: February 2017