NCT00004920

Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura

Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• 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. It is not yet known whether receiving cisplatin with raltitrexed is more effective than cisplatin alone for malignant mesothelioma. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without raltitrexed in treating patients who have malignant mesothelioma of the pleura.

Detailed description

OBJECTIVES: * Compare overall survival in patients with malignant pleural mesothelioma treated with raltitrexed with or without cisplatin. * Assess toxicity, progression free survival, and quality of life with these treatment regimens in these patients. * Evaluate objective response and duration of response to these treatment regimens in patients with measurable disease. OUTLINE: This is a randomized, open, multicenter study. Patients are stratified according to performance status (0 vs 1-2) and WBC count (less than 8,300/mm3 vs 8,300/mm3 or more). Patients are randomized to one of two treatment arms. * Arm I: Patients receive cisplatin IV over 1-2 hours on day 1. * Arm II: Patients receive raltitrexed IV over 15 minutes followed by cisplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before study, prior to each course, after the last course, and then every 6 weeks for 1 year. Patients are followed every 6 weeks until death. PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study over 24 months.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	raltitrexed

Timeline

• Start date: 1999-11-01
• Primary completion: 2003-01-01
• First posted: 2003-01-27
• Last updated: 2012-07-18

Locations

26 sites across 11 countries: Belgium, Canada, Egypt, France, Germany, Italy, Netherlands, Peru, Poland, Switzerland, United Kingdom