RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether Onconase plus doxorubicin is more effective than doxorubicin alone in treating patients with malignant mesothelioma. PURPOSE: This randomized phase III trial is studying doxorubicin alone to see how well it works compared to doxorubicin and Onconase in treating patients with malignant mesothelioma.
OBJECTIVES: * Compare the efficacy of doxorubicin with or without ranpirnase in patients with malignant pleural or peritoneal mesothelioma. * Compare the safety profile of these regimens in these patients. * Compare the overall survival, progression-free survival, and quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to disease histology (epithelioid vs nonepithelioid) and CALGB groups 1-4. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive ranpirnase IV over 30 minutes weekly followed by doxorubicin IV. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression. Patients demonstrating evidence of clinical response or stable disease may continue on maintenance therapy with ranpirnase as a single agent until disease progression. * Arm II: Patients receive doxorubicin as in arm I for up to 6 courses. Quality of life is assessed. PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Given IV
Given IV
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles
Saint Charles, Missouri, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Asklepios Fachkliniken Muenchen-Gauting
Gauting, Germany
Hospital Grosshansdorf
Großhansdorf, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
...and 9 more locations
Survival
Objective response
Time to best response
Response duration
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