ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
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|ClinicalTrials.gov Identifier: NCT00003034|
Recruitment Status : Unknown
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Drug: doxorubicin hydrochloride Drug: ranpirnase||Phase 3|
- 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 (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Masking:||None (Open Label)|
|Official Title:||ONCONASE Plus Doxorubicin Versus Doxorubicin For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen|
|Study Start Date :||May 1997|
|Estimated Primary Completion Date :||February 2008|
Experimental: 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.
Drug: doxorubicin hydrochloride
Experimental: Arm II
Patients receive doxorubicin as in arm I for up to 6 courses.
Drug: doxorubicin hydrochloride
- Objective response
- Time to best response
- Response duration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003034
|Study Chair:||Diane Scudiery||Alfacell|