ONCONASE Plus Doxorubicin Versus Doxorubicin For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Survival
No
Diane Scudiery
Study Chair
Alfacell
United States: Federal Government
CDR0000065639
NCT00003034
May 1997
Name | Location |
---|---|
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 |