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


Phase 3
21 Years
N/A
Open (Enrolling)
Both
Malignant Mesothelioma

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Survival

Safety Issue:

No

Principal Investigator

Diane Scudiery

Investigator Role:

Study Chair

Investigator Affiliation:

Alfacell

Authority:

United States: Federal Government

Study ID:

CDR0000065639

NCT ID:

NCT00003034

Start Date:

May 1997

Completion Date:

Related Keywords:

  • Malignant Mesothelioma
  • localized malignant mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • Mesothelioma

Name

Location

CCOP - DuluthDuluth, Minnesota  55805
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Missouri Cancer Care, PC at St. Joseph Health Center - St. CharlesSt. Charles, Missouri  63301
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199