Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma
Summary
This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma, including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic. Participants may be either previously untreated or treated with chemotherapy. Participants will accrue to two strata based on pre-treatment status; separate response rates and statistical operating characteristics will be applied to each stratum. The primary objective is to determine the objective response rate (complete plus partial) of XELOX in this population. Secondary objectives include determining toxicity, stable disease rates, and median and overall survival of participants treated with this combination.
Timeline
- Start
- 2003-08
- Primary completion
- 2009-05
- Completion
- 2009-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1500 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |