ONCONASE Plus Doxorubicin Versus Doxorubicin For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
- 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
- Arm II: Patients receive doxorubicin as in arm I for up to 6 courses. Quality of life
PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
|CCOP - Duluth
|Duluth, Minnesota 55805
|CCOP - Northern Indiana CR Consortium
|South Bend, Indiana 46601
|University of New Mexico Cancer Research and Treatment Center
|Albuquerque, New Mexico 87131
|Greenebaum Cancer Center at University of Maryland Medical Center
|Baltimore, Maryland 21201
|Spectrum Health Hospital - Butterworth Campus
|Grand Rapids, Michigan 49503
|Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles
|St. Charles, Missouri 63301
|Methodist Estabrook Cancer Center
|Omaha, Nebraska 68114-4199