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

NCT ID: NCT00003034

Last Updated: 2013-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-05-31

Brief 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.

Detailed 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.

Conditions

Malignant Mesothelioma

Keywords

localized malignant mesothelioma; advanced malignant mesothelioma; recurrent malignant mesothelioma

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

doxorubicin hydrochloride

Intervention Type: DRUG

Given IV

ranpirnase

Intervention Type: DRUG

Given IV

Arm II

Patients receive doxorubicin as in arm I for up to 6 courses.

Group Type: EXPERIMENTAL

doxorubicin hydrochloride

Intervention Type: DRUG

Given IV

Interventions

doxorubicin hydrochloride

Given IV

Intervention Type: DRUG

ranpirnase

Given IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alfacell

INDUSTRY

Sponsor Role: lead

Principal Investigators

Diane Scudiery

Role: STUDY_CHAIR

Alfacell

Locations

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Spectrum Health Hospital - Butterworth Campus

Grand Rapids, Michigan, United States

CCOP - Duluth

Duluth, Minnesota, United States

Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles

Saint Charles, Missouri, United States

Methodist Estabrook Cancer Center

Omaha, Nebraska, United States

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, United States

Asklepios Fachkliniken Muenchen-Gauting

Gauting, , Germany

Hospital Grosshansdorf

Großhansdorf, , Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

Asklepios Klinik Harburg

Hamburg, , Germany

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, , Germany

Istituto Nazionale per la Ricerca sul Cancro

Genoa, , Italy

Ospedale San Martino

Genoa, , Italy

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, , Italy

Medical University of Gdansk

Gdansk, , Poland

University School of Medical Sciences

Poznan, , Poland

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, , Poland

Klinika Chrorob Pluc I Gruzlicy

Zabrze, , Poland

Countries

Australia; Brazil; Canada; Mexico; New Zealand; United States; Germany; Italy; Poland

Other Identifiers

ALFACELL-P30-302

Identifier Type: -

Identifier Source: secondary_id

NCI-V97-1273

Identifier Type: -

Identifier Source: secondary_id

CDR0000065639

Identifier Type: -

Identifier Source: org_study_id