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

Phase 3

Completed

• Conditions: Malignant Mesothelioma

• Registration Number: NCT00004920
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 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.

Study Timeline

• Study Start: 1999-11
• Study First Submitted: 2000-03-07
• Primary Completion: 2003-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (26)

Western General Hospital; 🇬🇧 Edinburgh, Scotland, United Kingdom

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Regional Lung Diseases Hospital; 🇵🇱 Poznan, Poland

Inselspital, Bern; 🇨🇭 Bern, Switzerland

Allan Blair Cancer Centre; 🇨🇦 Regina, Saskatchewan, Canada

University Hospital; 🇨🇭 Basel, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Weston Park Hospital; 🇬🇧 Sheffield, England, United Kingdom

National Cancer Institute of Egypt; 🇪🇬 Cairo, Egypt

McGill University; 🇨🇦 Montreal, Quebec, Canada

University Hospital - Rotterdam Dijkzigt; 🇳🇱 Rotterdam, Netherlands

Academisch Ziekenhuis Utrecht; 🇳🇱 Utrecht, Netherlands

Thoraxklinik Rohrbach; 🇩🇪 Heidelberg, Germany

Nottingham City Hospital NHS Trust; 🇬🇧 Nottingham, England, United Kingdom

Medical University of Gdansk; 🇵🇱 Gdansk, Poland

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Instituto de Enfermedades Neoplasicas; 🇵🇪 Lima, Peru

Trillium Health Centre; 🇨🇦 Mississauga, Ontario, Canada

Hopital Charles Nicolle; 🇫🇷 Rouen, France

Assistance Publique Hopitaux de Marseille Hopitaux Sud; 🇫🇷 Marseille, France

Cancer Care Ontario-Hamilton Regional Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Cancer Care Ontario-London Regional Cancer Centre; 🇨🇦 London, Ontario, Canada

Istituto Nazionale per la Ricerca sul Cancro; 🇮🇹 Genoa (Genova), Italy

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Hopital de la Conception; 🇫🇷 Marseille, France