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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Mesothelioma

Intervention / Treatment
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* Drug: doxorubicin hydrochloride
* Drug: ranpirnase


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed malignant pleural or peritoneal mesothelioma Measurable or evaluable disease CALGB groups 1-4 No CNS metastases PATIENT CHARACTERISTICS: Age: 21 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 3,500/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: SGOT no greater than 2 times upper limit of normal Bilirubin no greater than 2 mg/dL PT and PTT normal Renal: Creatinine normal Cardiovascular: No symptomatic New York Heart Association class II-IV cardiovascular disease No congestive heart failure No angina pectoris No cardiac arrhythmias No uncontrolled hypertension No cerebrovascular disease Metabolic: No serum calcium, phosphate, electrolyte, or other metabolic abnormalities, such as metabolic acidosis Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious infection No uncontrolled psychosis or neurologic disease (e.g., seizure disorders) No uncontrolled diabetes mellitus No other primary malignancy within the past 5 years except nonmelanoma skin cancer No senility or emotional instability PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than one prior systemic chemotherapy regimen No prior doxorubicin At least 6 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy for progressive or recurrent disease allowed except myocardium radiotherapy Surgery: Prior surgical resection allowed

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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<br>* Given IV<br>Drug: ranpirnase<br>* Given IV<br>|
| Experimental: Arm II<br>Patients receive doxorubicin as in arm I for up to 6 courses. | Drug: doxorubicin hydrochloride<br>* Given IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response |  |  | 
| Time to best response |  |  | 
| Response duration |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma