Back to resultsONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
Primary Purpose
Malignant Mesothelioma
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
doxorubicin hydrochloride
ranpirnase
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Mesothelioma focused on measuring localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma
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
Sites / Locations
- CCOP - Northern Indiana CR Consortium
- Greenebaum Cancer Center at University of Maryland Medical Center
- Spectrum Health Hospital - Butterworth Campus
- CCOP - Duluth
- Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles
- Methodist Estabrook Cancer Center
- University of New Mexico Cancer Research and Treatment Center
- Asklepios Fachkliniken Muenchen-Gauting
- Hospital Grosshansdorf
- Asklepios Klinik St. Georg
- Asklepios Klinik Harburg
- Klinikum Rechts Der Isar - Technische Universitaet Muenchen
- Istituto Nazionale per la Ricerca sul Cancro
- Ospedale San Martino
- Fondazione I.R.C.C.S. Policlinico San Matteo
- Medical University of Gdansk
- University School of Medical Sciences
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
- Klinika Chrorob Pluc I Gruzlicy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm I
Arm II
Arm 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.
Patients receive doxorubicin as in arm I for up to 6 courses.
Outcomes
Primary Outcome Measures
Survival
Secondary Outcome Measures
Objective response
Time to best response
Response duration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00003034
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 1997 (undefined)
Primary Completion Date
February 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alfacell
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Mesothelioma
Keywords
localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm 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.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive doxorubicin as in arm I for up to 6 courses.
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
ranpirnase
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Survival
Secondary Outcome Measure Information:
Title
Objective response
Title
Time to best response
Title
Response duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Scudiery
Organizational Affiliation
Alfacell
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Spectrum Health Hospital - Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805-1983
Country
United States
Facility Name
Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Methodist Estabrook Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4199
Country
United States
Facility Name
University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
Asklepios Fachkliniken Muenchen-Gauting
City
Gauting
ZIP/Postal Code
D-82131
Country
Germany
Facility Name
Hospital Grosshansdorf
City
Grosshansdorf
ZIP/Postal Code
D-22927
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
Asklepios Klinik Harburg
City
Hamburg
ZIP/Postal Code
D-21075
Country
Germany
Facility Name
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale San Martino
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione I.R.C.C.S. Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
University School of Medical Sciences
City
Poznan
ZIP/Postal Code
PL-60 569
Country
Poland
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Klinika Chrorob Pluc I Gruzlicy
City
Zabrze
ZIP/Postal Code
41-803
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
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