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

Sponsor:	Alfacell
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003034

Purpose

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.

Condition	Intervention	Phase
Malignant Mesothelioma	Drug: doxorubicin hydrochloride Drug: ranpirnase	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Ranpirnase

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response [ Designated as safety issue: No ]
Time to best response [ Designated as safety issue: No ]
Response duration [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	May 1997
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: doxorubicin hydrochloride Given IV Drug: ranpirnase Given IV
Arm II: Experimental Patients receive doxorubicin as in arm I for up to 6 courses.	Drug: doxorubicin hydrochloride Given IV

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003034

Locations

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

Sponsors and Collaborators

Alfacell

Investigators

Study Chair:

Diane Scudiery

Alfacell

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000065639, ALFACELL-P30-302, NCI-V97-1273
Study First Received:	November 1, 1999
Last Updated:	April 26, 2009
ClinicalTrials.gov Identifier:	NCT00003034 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Ranpirnase
Neoplasms, Mesothelial
Antineoplastic Agents
Enzyme Inhibitors
Antibiotics, Antineoplastic
Doxorubicin

Pharmacologic Actions
Protein Synthesis Inhibitors
Neoplasms
Therapeutic Uses
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010