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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017459 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: tirapazamine Drug: vinorelbine ditartrate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | The International Tirazone Triple Trial (i3T): A Phase III, Randomzied 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 Start Date: | July 2000 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIB or IV Newly diagnosed or recurrent disease Measurable lesions At least 10 mm by spiral CT scan OR At least 20 mm by conventional techniques Previously irradiated lesions are considered measurable provided they progressed or appeared after completion of radiotherapy The following are considered nonmeasurable: Pleural or pericardial effusions Cystic lesions Lymphangitis pulmonis Bony x-ray abnormalities Abnormal scans with nonmeasurable filling defects No symptomatic brain metastasis or CNS involvement by CT scan or MRI
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine normal Other: No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell carcinoma that is not likely to recur No history of allergic reactions to diuretics or antiemetics (e.g., 5-HT3 antagonists) used on this study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biologic therapy for NSCLC Chemotherapy: No prior chemotherapy for NSCLC No prior platinum-based chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to potential indicator lesion(s) At least 4 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgical procedure(s) Other: At least 30 days since prior investigational drug
Contacts and Locations
Hide Study Locations| United States, California | |
| Bay Area Tumor Institute | |
| Oakland, California, United States, 94609 | |
| John Wayne Cancer Institute | |
| Santa Monica, California, United States, 90404 | |
| Los Angeles County Harbor-UCLA Medical Center | |
| Torrance, California, United States, 90509 | |
| Medical Oncology Care Associates | |
| Orange, California, United States, 92668 | |
| Medical Oncology Internal Medicine | |
| Los Angeles, California, United States, 90067 | |
| Tower Hematology Oncology Medical Group | |
| Los Angeles, California, United States, 90048 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94143-0128 | |
| United States, Delaware | |
| Medical Oncology-Hematology Consultants, P.A. | |
| Wilmington, Delaware, United States, 19808 | |
| United States, District of Columbia | |
| Veterans Affairs Medical Center - Washington, DC | |
| Washington, District of Columbia, United States, 20422 | |
| Washington Cancer Institute | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Ocala Oncology Center | |
| Ocala, Florida, United States, 34474 | |
| Ocala Research Institute, Inc | |
| Ocala, Florida, United States, 34471 | |
| University of Florida Health Science Center - Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| Watson Clinic | |
| Lakeland, Florida, United States, 33804-5000 | |
| United States, Idaho | |
| Saint Alphonsus Regional Medical Center | |
| Boise, Idaho, United States, 83706 | |
| United States, Illinois | |
| Dreyer Medical Clinic | |
| Aurora, Illinois, United States, 60506 | |
| Northwest Oncology and Hematology, S.C. | |
| Elk Grove Village, Illinois, United States, 60007 | |
| Rockford Clinic | |
| Rockford, Illinois, United States, 61103 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| Cancer Care Center | |
| New Albany, Indiana, United States, 47150 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Louisiana | |
| Hematology-Oncology Clinic | |
| Baton Rouge, Louisiana, United States, 70808 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Capitol Comprehensive Cancer Care Clinic | |
| Jefferson City, Missouri, United States, 65109 | |
| St. John's Mercy Medical Center | |
| Saint Louis, Missouri, United States, 63141 | |
| Veterans Affairs Medical Center - Kansas City | |
| Kansas City, Missouri, United States, 64128 | |
| United States, Montana | |
| Western Montana Clinic | |
| Missoula, Montana, United States, 59803 | |
| United States, New Jersey | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07018-1095 | |
| United States, New York | |
| Brookdale University Hospital and Medical Center | |
| Brooklyn, New York, United States, 11212 | |
| Interlakes Oncology/Hematology PC | |
| Rochester, New York, United States, 14623 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, Ohio | |
| Akron General Medical Center | |
| Akron, Ohio, United States, 44302 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Fox Chase - Temple Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| North Penn Hospital | |
| Lansdale, Pennsylvania, United States, 19446-1200 | |
| United States, Texas | |
| Baptist Health System Cancer Program | |
| San Antonio, Texas, United States, 78205 | |
| Cancer Therapy Research Center | |
| San Antonio, Texas, United States, 78229 | |
| Center for Oncology Research and Treatment, Medical City Hospital | |
| Dallas, Texas, United States, 75230 | |
| Lone Star Oncology | |
| Austin, Texas, United States, 78759 | |
| Southwest Cancer Center at University Medical Center | |
| Lubbock, Texas, United States, 79415 | |
| Veterans Affairs Medical Center - Temple | |
| Temple, Texas, United States, 76504 | |
| United States, Virginia | |
| Arlington-Fairfax Hematology/Oncology, PC | |
| Arlington, Virginia, United States, 22205 | |
| Study Chair: | Elwyn Y. Loh, MD | Sanofi-Aventis |
More Information
| Study ID Numbers: | CDR0000068690, SANOFI-EFC3675 |
| Study First Received: | June 6, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00017459 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Vinblastine Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Respiratory Tract Neoplasms Neoplasms by Histologic Type Mitosis Modulators |
Antimitotic Agents Pharmacologic Actions Carcinoma Neoplasms Vinorelbine Radiation-Sensitizing Agents Lung Diseases Tubulin Modulators Tirapazamine Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
