Trial | NCT00003034  Report issue

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    300
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.
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 Started
May 31
1997
Primary Completion
Feb 29
2008
Anticipated
Last Update
Nov 06
2013
Estimate

Drug ranpirnase

Given IV

Drug doxorubicin hydrochloride

Given IV

Arm I Experimental

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 Experimental

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

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
No Results Posted