The International Tirazone Triple Trial (i3T): A Phase III, Randomized Efficacy And Safety Study Of The Combination Chemotherapy With Tirapazamine+Cisplatin+Vinorelbine Versus Cisplatin+Vinorelbine In Subjects With Inoperable, Previously Untreated, Non-Small Cell Lung Cancer
OBJECTIVES: I. Compare the overall survival duration of patients with stage IIIB or IV
non-small cell lung cancer treated with vinorelbine and cisplatin with or without
tirapazamine. II. Compare the complete and partial response rates, time to disease
progression, and time to treatment failure in these patients treated with these regimens.
III. Compare the clinical benefit of these regimens, in terms of performance status and body
weight, in these patients. IV. Compare the toxicity and safety of these regimens in these
patients. V. Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms. Arm I: Patients receive tirapazamine IV over 2 hours followed by cisplatin
IV over 1 hour on day 1. Patients also receive vinorelbine IV over 6-10 minutes on days 1,
8, 15, and 22. Arm II: Patients receive cisplatin and vinorelbine as in arm I. Treatment
repeats every 28 days for a total of 6 courses in the absence of disease progression or
unacceptable toxicity. Quality of life is assessed at baseline, during each course of
treatment, at 30 days after the last course of treatment, and then every 8 weeks for 2-3
years. Patients are followed every 8 weeks for 2-3 years.
PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Elwyn Y. Loh, MD
Study Chair
Sanofi
United States: Federal Government
CDR0000068690
NCT00017459
July 2000
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
Fox Chase - Temple Cancer Center | Philadelphia, Pennsylvania 19111-2442 |
New York Medical College | Valhalla, New York 10595 |
Akron General Medical Center | Akron, Ohio 44302 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
John Wayne Cancer Institute | Santa Monica, California 90404 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
Rockford Clinic | Rockford, Illinois 61103 |
Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
Brookdale University Hospital and Medical Center | Brooklyn, New York 11212 |
Capitol Comprehensive Cancer Care Clinic | Jefferson City, Missouri 65109 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
Ocala Oncology Center | Ocala, Florida 34474 |
North Penn Hospital | Lansdale, Pennsylvania 19446-1200 |
Lone Star Oncology | Austin, Texas 78759 |
University of Florida Health Science Center - Jacksonville | Jacksonville, Florida 32209 |
Northwest Oncology and Hematology, S.C. | Elk Grove Village, Illinois 60007 |
Washington Cancer Institute | Washington, District of Columbia 20010 |
Cancer Care Center | New Albany, Indiana 47150 |
St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Watson Clinic | Lakeland, Florida 33805 |
Tower Hematology Oncology Medical Group | Los Angeles, California 90048 |
Center for Oncology Research and Treatment, Medical City Hospital | Dallas, Texas 75230 |
Medical Oncology Internal Medicine | Los Angeles, California 90067 |
Bay Area Tumor Institute | Oakland, California 94609 |
Medical Oncology Care Associates | Orange, California 92668 |
Dreyer Medical Clinic | Aurora, Illinois 60506 |
Baptist Health System Cancer Program | San Antonio, Texas 78205 |
Western Montana Clinic | Missoula, Montana 59807-7609 |
Los Angeles County Harbor-UCLA Medical Center | Torrance, California 90509 |
Medical Oncology-Hematology Consultants, P.A. | Wilmington, Delaware 19808 |
Ocala Research Institute, Inc | Ocala, Florida 34471 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Hematology-Oncology Clinic | Baton Rouge, Louisiana 70808 |
Southwest Cancer Center at University Medical Center | Lubbock, Texas 79415 |
Cancer Therapy Research Center | San Antonio, Texas 78229 |
Arlington-Fairfax Hematology/Oncology, PC | Arlington, Virginia 22205 |