Gallbladder Cancer Clinical Trial
Official title:
A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, use different
ways to stop tumor cells from dividing so they stop growing or die. Combining more than one
drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with
capecitabine in treating patients who have locally advanced or metastatic gallbladder cancer
or cholangiocarcinoma.
OBJECTIVES:
- Determine the response rates (confirmed complete and partial responses) in patients
with unresectable, locally advanced or metastatic gallbladder cancer or
cholangiocarcinoma treated with gemcitabine and capecitabine.
- Determine the overall survival of patients treated with this regimen.
- Determine the quantitative and qualitative toxic effects of this regimen in these
patients.
- Determine the feasibility of accruing patients with these disease sites.
- Evaluate, preliminarily, relevant prognostic markers in these disease sites and the
prognostic implications as predictors of survival in patients treated with this
regimen.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14 and gemcitabine IV over 100
minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for
up to 3 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within
approximately 10-20 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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