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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alfacell
• Treatments: Doxorubicin; Liposomal doxorubicin; Ranpirnase

Criteria

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