A Single-Blind Randomized Phase III Trial of MTA Plus Cisplatin Versus Cisplatin in Patients With Malignant Pleural Mesothelioma
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.
Allocation: Randomized, Primary Purpose: Treatment
David H. Ilson, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|