Pain Clinical Trial
Official title:
Capecitabine And Gemcitabine In Patients With Advanced Or Metastatic Biliary Tract Cancer, A Multicenter Phase II Trial
RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, use different
ways to stop tumor cells from dividing so they stop growing or die. Palliative chemotherapy
may improve the quality of life in patients who have locally advanced or metastatic biliary
tract cancer and may help them live more comfortably.
PURPOSE: Phase II trial to study the effectiveness of adjuvant capecitabine and gemcitabine
in improving quality of life in patients who have locally advanced or metastatic biliary
tract cancer.
OBJECTIVES:
Primary
- Determine the ability of palliative capecitabine and gemcitabine to maintain or improve
tumor-related symptoms (after treatable biliary duct obstruction has been relieved) as
measured by the clinical benefit response in patients with locally advanced or
metastatic biliary tract cancer.
Secondary
- Determine the clinical benefit response in patients treated with this regimen.
- Determine the time to and duration of clinical benefit response in patients treated
with this regimen.
- Determine the objective response and time to progression in patients treated with this
regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the adverse events in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice
daily on days 1-14 (28 total doses). Treatment repeats every 21 days for 8 courses in the
absence of disease progression or unacceptable toxicity. Patients responding to treatment
may receive additional courses at the discretion of the investigator.
Quality of life is assessed at baseline, weekly during weeks 2-9 (courses 1-3), and then
before each administration of gemcitabine.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 19-44 patients will be accrued for this study within 3 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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