ONCONASE Plus Doxorubicin Versus Doxorubicin For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
doxorubicin hydrochloride
+ ranpirnase
+ doxorubicin hydrochloride
Adenoma+11
+ Lung Diseases
+ Lung Neoplasms
Treatment Study
Summary
Study start date: May 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 19 locations
CCOP - Northern Indiana CR Consortium
South Bend, United StatesOpen CCOP - Northern Indiana CR Consortium in Google MapsGreenebaum Cancer Center at University of Maryland Medical Center
Baltimore, United StatesSpectrum Health Hospital - Butterworth Campus
Grand Rapids, United StatesCCOP - Duluth
Duluth, United States