A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
- Determine the response rate in patients with advanced and/or inoperable
cholangiocarcinoma or carcinoma of the gallbladder treated with gemcitabine and
- Determine time to disease progression and overall survival of patients treated with
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Milind Javle, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|