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

Brief Title

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

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

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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Survival

Secondary Outcome

 Objective response

Condition

Malignant Mesothelioma

Intervention

doxorubicin hydrochloride

Study Arms / Comparison Groups

 Arm I

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

300

Start Date

May 1997

Primary Completion Date

February 2008

Eligibility 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
      

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Diane Scudiery, , 

Location Countries

Germany

Location Countries

Germany

NCT ID

NCT00003034

Organization ID

CDR0000065639

Secondary IDs

ALFACELL-P30-302

Study Sponsor

Alfacell

Study Sponsor

Diane Scudiery, Study Chair, Alfacell

Verification Date

October 2007