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

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

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

Brief 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 Summary:

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.


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: March 7, 2000
Date Started: November 1999
Date Completion:
Last Updated: July 17, 2012
Last Verified: July 2012