Spots Global Cancer Trial Database for Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
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Trial Identification
Brief Title: Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
Official Title: A PHASE III, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MARIMASTAT IN PATIENTS WITH MINIMAL DISEASE STAGE III NON-SMALL CELL LUNG CANCER
Study ID: NCT00002911
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Marimastat may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. 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: OBJECTIVES: I. Compare the effect of marimastat (a matrix metalloproteinase inhibitor) vs. placebo on overall survival in patients with Stage III non-small cell lung cancer who have minimal residual disease following chemotherapy, radiotherapy, and/or surgery. II. Assess the effect of marimastat on time to disease progression in these patients. III. Assess the safety and tolerability of marimastat in these patients. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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, Saint 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
Contact Details
Name: Kathleen Heck, MEd, MBA
Affiliation: ILEX Oncology Services, Incorporated
Role: STUDY_CHAIR
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