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

Malignant Mesothelioma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003034
• Other study ID #: CDR0000065639
• Secondary ID: ALFACELL-P30-302
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: November 5, 2013
• Start date: May 1997

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma

Intervention

Drug:
• doxorubicin hydrochloride
Given IV
• ranpirnase
Given IV

Locations

Country	Name	City	State
Germany	Asklepios Fachkliniken Muenchen-Gauting	Gauting
Germany	Hospital Grosshansdorf	Grosshansdorf
Germany	Asklepios Klinik Harburg	Hamburg
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Klinikum Rechts Der Isar - Technische Universitaet Muenchen	Munich
Italy	Istituto Nazionale per la Ricerca sul Cancro	Genoa
Italy	Ospedale San Martino	Genoa
Italy	Fondazione I.R.C.C.S. Policlinico San Matteo	Pavia
Poland	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
United States	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	CCOP - Duluth	Duluth	Minnesota
United States	Spectrum Health Hospital - Butterworth Campus	Grand Rapids	Michigan
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles	St. Charles	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Alfacell

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival			No
Secondary	Objective response			No
Secondary	Time to best response			No
Secondary	Response duration			No