Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
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|ClinicalTrials.gov Identifier: NCT00004920|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Drug: cisplatin Drug: raltitrexed||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|Official Title:||Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma|
|Study Start Date :||November 1999|
|Actual Primary Completion Date :||January 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004920
|Study Chair:||Jan P. Van Meerbeeck, MD, PhD||University Medical Center Rotterdam at Erasmus Medical Center|