NCT00004183

Capecitabine in Treating Patients With Malignant Mesothelioma

Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	capecitabine

Timeline

• Start date: 2000-11-01
• Primary completion: 2003-12-01
• Completion: 2006-01-01
• First posted: 2004-02-25
• Last updated: 2016-07-14

Locations

50 sites across 1 country: United States