Gemcitabine and Capecitabine in Treating Patients With Advanced and/or Inoperable Cholangiocarcinoma or Carcinoma of the Gallbladder
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced and/or inoperable cholangiocarcinoma or carcinoma (cancer) of the gallbladder.
|Extrahepatic Bile Duct Cancer Gallbladder Cancer||Drug: capecitabine Drug: gemcitabine hydrochloride||Phase 2|
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma|
|Study Start Date:||October 2002|
|Study Completion Date:||November 2006|
|Primary Completion Date:||May 2004 (Final data collection date for primary outcome measure)|
- Determine the response rate in patients with advanced and/or inoperable cholangiocarcinoma or carcinoma of the gallbladder treated with gemcitabine and capecitabine.
- Determine time to disease progression and overall survival of patients treated with this regimen.
- Determine quality of life of patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at weeks 3, 6, 9, and 12.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 9-17 patients will be accrued for this study within 1.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084942
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Milind Javle, MD||Roswell Park Cancer Institute|
|Principal Investigator:||John Gibbs, MD||Roswell Park Cancer Institute|