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

• Survival [ Designated as safety issue: No ]
  

• Objective response [ Designated as safety issue: No ]
  
• Time to best response [ Designated as safety issue: No ]
  
• Response duration [ Designated as safety issue: No ]
  

OBJECTIVES:

• Compare the efficacy of doxorubicin with or without Onconase 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 Onconase 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 Onconase 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.

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