Gallbladder Cancer Clinical Trial
Official title:
A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
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.
OBJECTIVES:
Primary
- Determine the response rate in patients with advanced and/or inoperable
cholangiocarcinoma or carcinoma of the gallbladder treated with gemcitabine and
capecitabine.
Secondary
- 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.
;
Masking: Open Label, Primary Purpose: Treatment
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