NCT00003034

ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen

ONCONASE Plus Doxorubicin Versus Doxorubicin For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Alfacell · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	doxorubicin hydrochloride	Given IV
DRUG	ranpirnase	Given IV

Timeline

• Start date: 1997-05-01
• Primary completion: 2008-02-01
• First posted: 2003-01-27
• Last updated: 2013-11-06

Locations

19 sites across 4 countries: United States, Germany, Italy, Poland