Clinical Trial: Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study on Tomusex in Malignant Mesothelioma

Brief 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 raltitrexed in treating patients who have malignant mesothelioma that cannot be surgically removed.

Detailed Summary:

OBJECTIVES: I. Determine the therapeutic activity and toxicities of raltitrexed in patients with inoperable malignant mesothelioma. II. Determine the objective response rate and duration of response in patients treated with this regimen.

OUTLINE: This is a multicenter study. Within 2 weeks of staging procedures, patients receive raltitrexed IV over 15 minutes on day 1. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and then every 8 weeks thereafter for survival.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: European Organisation for Research and Treatment of Cancer - EORTC

Dates:
Date Received: January 28, 2000
Date Started: November 1999
Date Completion:
Last Updated: July 17, 2012
Last Verified: July 2012