Capecitabine in Treating Patients With Malignant Mesothelioma
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.
|Study Design:||Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study|
|Study Start Date:||November 2000|
|Study Completion Date:||January 2006|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
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.