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About
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.
Full description
OBJECTIVES:
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.
PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study.
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DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural or peritoneal mesothelioma
CALGB groups 1-4
No CNS metastases
PATIENT CHARACTERISTICS:
Age:
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Hematopoietic:
Hepatic:
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PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
300 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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