Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
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 if cisplatin is more effective with or without pemetrexed disodium for malignant mesothelioma of the pleura.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without pemetrexed disodium in treating patients who have malignant mesothelioma of the pleura that cannot be removed by surgery.
Drug: pemetrexed disodium
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Single-Blind Randomized Phase III Trial of MTA Plus Cisplatin Versus Cisplatin in Patients With Malignant Pleural Mesothelioma|
|Study Start Date:||November 1999|
|Study Completion Date:||November 2000|
|Primary Completion Date:||November 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Compare survival in patients with malignant pleural mesothelioma when treated with cisplatin with or without LY231514. II. Compare duration of response, time to progression, and time to treatment failure in these patients with these treatment regimens. III. Compare tumor response rate and clinical benefit of these treatment regimens in these patients. IV. Compare Lung Cancer Symptom Scale scores, pulmonary function test scores, and lung density determinations with these treatment regimens in these patients. V. Compare toxicity of these treatment regimens in these patients. VI. Assess pharmacokinetics and vitamin metabolite status with these treatment regimens in these patients.
OUTLINE: This is a randomized, single blind, multicenter study. Patients are stratified according to performance status (Karnofsky 70-80% vs 90-100%), degree of measurability (bidimensional vs unidimensional only), histologic subtype (epithelial vs all others), WBC (8,300/mm3 and higher vs less than 8,300/mm3), pain intensity (low vs high), analgesic consumption (low vs high), dyspnea (low vs high), homocysteine (low vs high), gender, country, and treatment center. Patients are randomized to one of two treatment arms. Arm I: Patients receive LY231514 IV over 10 minutes followed by cisplatin IV over 2 hours on day 1. Arm II: Patients receive cisplatin as in arm I. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study within 15 months.
|United States, New Jersey|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||David H. Ilson, MD, PhD||Memorial Sloan-Kettering Cancer Center|