NCT00626158

Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers

A Phase I Study, With Expanded Cohort, of Biweekly Fixed-dose Rate Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic and Biliary Carcinomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what effects gemcitabine plus capecitabine has on patients with pancreatic or biliary cancer, and to determine the optimal dose that can be given safely of these two drugs together (called the maximum tolerated dose). Gemcitabine and capecitabine are two chemotherapy drugs used to treat pancreatic and biliary cancer. These two drugs used together are considered an acceptable standard of care for pancreatic and biliary cancers. However, in this study the dose and dosing schedule will be changed, in the hopes that the drugs will have more effect with fewer side effects than when given in the standard way.

Conditions

• Pancreatic Cancer
• Biliary Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine	1000 mg/m2 IV day 1 of every cycle for 100 minutes (each cycle 14 days)
DRUG	capecitabine	starting dose 1000 mg/m2 PO twice a day for days 1-7 of each cycle (each cycle 14 days)

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-02-29
• Last updated: 2012-04-04

Locations

2 sites across 1 country: United States