Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
NCT ID: NCT00002911
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1996-12-31
2004-05-31
Brief Summary
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PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of marimastat in treating patients who have residual stage III non-small cell lung cancer.
Detailed Description
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OUTLINE: This is a randomized, double-blind study. Patients are randomized no less than 2 and no more than 8 weeks after the last prior treatment modality received. Patients are stratified by participating institution. Patients are randomly assigned to receive either oral marimastat or oral placebo twice daily. Treatment begins within 5 days of minimization and continues for up to 18 months after the last patient is enrolled, unless disease progression or unacceptable toxicity intervenes. Patients deriving benefit at end of study may continue treatment if desired. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 504 patients will be entered over 30 months from approximately 60 centers.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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marimastat
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: Absolute neutrophil count greater than 500/mm3 Platelet count greater than 50,000/mm3 Hepatic: Bilirubin less than 2.0 times upper limit of normal (ULN) AST/ALT no greater than 3.0 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No acute illness within 1 week of start of study No other illness that would significantly interfere with study outcome No major medical illness that precludes prolonged marimastat administration No second malignancy within 5 years except: Adequately treated basal cell carcinoma of the skin In situ carcinoma of the cervix Not pregnant or nursing Medically approved method of contraception required of fertile women Willing and able to tolerate and comply with study requirements
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior marimastat, batimastat, bleomycin, or busulphan No more than 1 cytotoxic chemotherapy regimen for non-small cell lung cancer Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: At least 4 weeks since any investigational drug therapies
18 Years
ALL
No
Sponsors
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ILEX Oncology Services, Incorporated
INDUSTRY
Principal Investigators
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Kathleen Heck, MEd, MBA
Role: STUDY_CHAIR
ILEX Oncology Services, Incorporated
Locations
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Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States
Hematology Associates, Ltd.
Phoenix, Arizona, United States
Marin Cancer Institute
Greenbrae, California, United States
Scripps Clinic
La Jolla, California, United States
Scripps Memorial Hospital Stevens Cancer Center
La Jolla, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
St. Joseph Hospital - Orange
Orange, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
University of Colorado Cancer Center
Denver, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C., District of Columbia, United States
Comprehensive Cancer Center at JFK Medical Center
Atlantis, Florida, United States
Radiation Therapy Associates - Fort Myers
Fort Myers, Florida, United States
Oncology-Hematology Group of South Florida
Miami, Florida, United States
Bay Area Oncology, MD'S, PA
Tampa, Florida, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Louisiana State University School of Medicine
New Orleans, Louisiana, United States
Hubert H. Humphrey Cancer Center
Coon Rapids, Minnesota, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Southwest Cancer Clinic
Henderson, Nevada, United States
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States
Beth Israel Medical Center
New York, New York, United States
Kaplan Cancer Center
New York, New York, United States
Strong Memorial Hospital of the University of Rochester
Rochester, New York, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Hematology-Oncology Mawr Medical North
Bryn Mawr, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Care Group
Philadelphia, Pennsylvania, United States
Allegheny University Hospitals - Graduate MCP
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Pittsburgh Pediatric Research, Inc.
Pittsburgh, Pennsylvania, United States
Roger Williams Medical Center/BUSM
Providence, Rhode Island, United States
Jackson Clinic Professional Association
Jackson, Tennessee, United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States
Texas Oncology PA (TOPA) at Baylor-Sammons
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Ottawa Regional Cancer Center - General Division
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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ILEX-C03-IVB/173
Identifier Type: -
Identifier Source: secondary_id
BB-C03-IVB/173
Identifier Type: -
Identifier Source: secondary_id
NCI-V96-1113
Identifier Type: -
Identifier Source: secondary_id
CDR0000065284
Identifier Type: -
Identifier Source: org_study_id