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

November 5, 2013 updated by: Alfacell

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Gauting, Germany, D-82131
        • Asklepios Fachkliniken Muenchen-Gauting
      • Grosshansdorf, Germany, D-22927
        • Hospital Grosshansdorf
      • Hamburg, Germany, D-20099
        • Asklepios Klinik St. Georg
      • Hamburg, Germany, D-21075
        • Asklepios Klinik Harburg
      • Munich, Germany, D-81675
        • Klinikum Rechts der Isar - Technische Universitaet Muenchen
  • Italy
      • Genoa, Italy, 16132
        • Istituto nazionale Per la Ricerca sul Cancro
      • Genoa, Italy, 16132
        • Ospedale San Martino
      • Pavia, Italy, 27100
        • Fondazione I.R.C.C.S. Policlinico San Matteo
  • Poland
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk
      • Poznan, Poland, PL-60 569
        • University School of Medical Sciences
      • Warsaw, Poland, 02-781
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
      • Zabrze, Poland, 41-803
        • Klinika Chrorob Pluc I Gruzlicy
  • United States
    • Indiana
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Hospital - Butterworth Campus
    • Minnesota
      • Duluth, Minnesota, United States, 55805-1983
        • CCOP - Duluth
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles
    • Nebraska
      • Omaha, Nebraska, United States, 68114-4199
        • Methodist Estabrook Cancer Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-5636
        • University of New Mexico Cancer Research and Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: doxorubicin hydrochloride
Given IV
Drug: ranpirnase
Given IV
Experimental: Arm II
Patients receive doxorubicin as in arm I for up to 6 courses.
Drug: doxorubicin hydrochloride
Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival

Secondary Outcome Measures

Outcome Measure
Objective response
Response duration
Time to best response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alfacell

Investigators

  • Study Chair: Diane Scudiery, Alfacell

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1997

Primary Completion (Anticipated)

February 1, 2008

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065639
  • ALFACELL-P30-302
  • NCI-V97-1273

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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