Overview

This trial is active, not recruiting.

Condition malignant mesothelioma
Treatments doxorubicin hydrochloride, ranpirnase
Phase phase 3
Sponsor Alfacell
Start date May 1997
End date February 2008
Trial size 300 participants
Trial identifier NCT00003034, ALFACELL-P30-302, CDR0000065639, NCI-V97-1273

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
doxorubicin hydrochloride
Given IV
ranpirnase
Given IV
(Experimental)
Patients receive doxorubicin as in arm I for up to 6 courses.
doxorubicin hydrochloride
Given IV

Primary Outcomes

Measure
Survival
time frame:

Secondary Outcomes

Measure
Objective response
time frame:
Time to best response
time frame:
Response duration
time frame:

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).