Cholangiocarcinoma Clinical Trial
Official title:
A Multicenter, Phase I-II Trial of Gemcitabine Plus Oxaliplatin and Nab-paclitaxel in Subjects With Advanced (Unresectable or Metastatic) Biliary Tract Cancer
The objective of the study is to determine a new combination of drug that improves the
outcome in patients with advanced (unresectable or metastatic) BTC. The primary objective of
the phase I part of the study is to determine the maximum tolerated dose (MTD) of the
combination gemcitabine plus oxaliplatin plus nab-paclitaxel, established in the first cycle
of therapy, in order to determine the recommended phase II dose (RP2D).
The primary objective of the phase II is to determine activity of GEMOX plus nab-paclitaxel.
The secondary objectives of the study consist in to better define the safety profile and the
outcome of the study treated population.
Systemic chemotherapy is increasingly being applied in cases of biliary tract cancers. A
benefit for chemotherapy over best supportive care alone was suggested in a trial that
randomly assigned 90 patients with advanced pancreatic or biliary cancer (37 with bile duct
cancer) to fluorouracil (FU)-based systemic chemotherapy or best supportive care alone
(median survival 6 versus 2.5 months, respectively) (1).
The literature regarding treatment results with specific regimens is limited because most
series are small, and many reports consist of a mix of bile duct cancers, gallbladder cancer,
ampullary cancer, and either pancreatic or hepatocellular cancers. Although they arise in
similar locations, these cancers all have a unique natural history and response to
chemotherapy. In general, no single drug or combination has consistently increased median
survival beyond the expected six to eight months.
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|---|---|---|---|
| Recruiting |
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