Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT00003034
Brief 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.
Study:
NCT00003034
Study Brief:
Protocol Section:
NCT00003034