Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma
- 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
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.
Allocation: Randomized, Primary Purpose: Treatment
Jan P. Van Meerbeeck, MD, PhD
University Medical Center Rotterdam at Erasmus Medical Center
United States: Federal Government