Malignant Mesothelioma Clinical Trial
Official title:
Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who
have malignant mesothelioma.
OBJECTIVES: I. Determine the response rate, overall survival, and failure free survival of
patients with malignant mesothelioma treated with capecitabine. II. Determine the toxicity
of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days
1-14. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease
progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every
3 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 7-9 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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