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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Kathleen Heck, MEd, MBA
Study Chair
ILEX Oncology Services, Incorporated
United States: Federal Government
CDR0000065284
NCT00002911
December 1996
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Kaplan Cancer Center | New York, New York 10016 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington, District of Columbia 20007 |
Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Baptist Regional Cancer Center - Knoxville | Knoxville, Tennessee 37901 |
Radiation Therapy Associates - Fort Myers | Fort Myers, Florida 33901 |
Community Hospitals of Indianapolis - Regional Cancer Center | Indianapolis, Indiana 46219 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
Beth Israel Medical Center | New York, New York 10003 |
Roger Williams Medical Center/BUSM | Providence, Rhode Island 02908-4735 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
John Wayne Cancer Institute | Santa Monica, California 90404 |
Scripps Clinic | La Jolla, California 92037 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
Comprehensive Cancer Institute of Huntsville | Huntsville, Alabama 35801 |
St. Joseph Hospital - Orange | Orange, California 92868 |
University of Connecticut Health Center | Farmington, Connecticut 06360-7106 |
Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Comprehensive Cancer Center at JFK Medical Center | Atlantis, Florida 33462 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
Hematology Associates, Ltd. | Phoenix, Arizona 85013 |
Marin Cancer Institute | Greenbrae, California 94904 |
Scripps Memorial Hospital Stevens Cancer Center | La Jolla, California 92037 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Oncology-Hematology Group of South Florida | Miami, Florida 33176 |
Bay Area Oncology, MD'S, PA | Tampa, Florida 33607-6381 |
Louisiana State University School of Medicine | New Orleans, Louisiana 70112-2822 |
Hubert H. Humphrey Cancer Center | Coon Rapids, Minnesota 55433 |
Southwest Cancer Clinic | Henderson, Nevada 89014 |
Strong Memorial Hospital of the University of Rochester | Rochester, New York 14642 |
Hematology-Oncology Mawr Medical North | Bryn Mawr, Pennsylvania 19010 |
Care Group | Philadelphia, Pennsylvania 19145 |
Allegheny University Hospitals - Graduate MCP | Philadelphia, Pennsylvania 19146 |
Pittsburgh Pediatric Research, Inc. | Pittsburgh, Pennsylvania 15216 |
Jackson Clinic Professional Association | Jackson, Tennessee 38301 |
Texas Oncology PA (TOPA) at Baylor-Sammons | Dallas, Texas 75246 |