Spots Global Cancer Trial Database for Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title: 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
Study ID: NCT00017459
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if cisplatin and vinorelbine are more effective with or without tirapazamine in treating non-small cell lung cancer PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus vinorelbine with or without tirapazamine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tower Hematology Oncology Medical Group, Los Angeles, California, United States
Medical Oncology Internal Medicine, Los Angeles, California, United States
Bay Area Tumor Institute, Oakland, California, United States
Medical Oncology Care Associates, Orange, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
John Wayne Cancer Institute, Santa Monica, California, United States
Los Angeles County Harbor-UCLA Medical Center, Torrance, California, United States
Medical Oncology-Hematology Consultants, P.A., Wilmington, Delaware, United States
Washington Cancer Institute, Washington, District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, United States
University of Florida Health Science Center - Jacksonville, Jacksonville, Florida, United States
Watson Clinic, Lakeland, Florida, United States
Ocala Research Institute, Inc, Ocala, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
Dreyer Medical Clinic, Aurora, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Northwest Oncology and Hematology, S.C., Elk Grove Village, Illinois, United States
Rockford Clinic, Rockford, Illinois, United States
Cancer Care Center, New Albany, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Hematology-Oncology Clinic, Baton Rouge, Louisiana, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Capitol Comprehensive Cancer Care Clinic, Jefferson City, Missouri, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
St. John's Mercy Medical Center, Saint Louis, Missouri, United States
Western Montana Clinic, Missoula, Montana, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
Brookdale University Hospital and Medical Center, Brooklyn, New York, United States
Interlakes Oncology/Hematology PC, Rochester, New York, United States
New York Medical College, Valhalla, New York, United States
Akron General Medical Center, Akron, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
North Penn Hospital, Lansdale, Pennsylvania, United States
Fox Chase - Temple Cancer Center, Philadelphia, Pennsylvania, United States
Lone Star Oncology, Austin, Texas, United States
Center for Oncology Research and Treatment, Medical City Hospital, Dallas, Texas, United States
Southwest Cancer Center at University Medical Center, Lubbock, Texas, United States
Baptist Health System Cancer Program, San Antonio, Texas, United States
Cancer Therapy Research Center, San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple, Temple, Texas, United States
Arlington-Fairfax Hematology/Oncology, PC, Arlington, Virginia, United States
Contact Details
Name: Elwyn Y. Loh, MD
Affiliation: Sanofi
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
