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Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical research trials and Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer. Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer  Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: Completed
Sponsor(s): Sanofi-Synthelabo ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ElwynLoh, Study Chair, Sanofi-Synthelabo
Interlakes Oncology/Hematology PC
Rochester, New York, 14623
United States
Watson Clinic
Lakeland, Florida, 33804-5000
United States
Medical Oncology Care Associates
Orange, California, 92668
United States
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109
United States
John Wayne Cancer Institute
Santa Monica, California, 90404
United States
Cancer Therapy Research Center
San Antonio, Texas, 78229
United States
New York Medical College
Valhalla, New York, 10595
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706
United States
Fox Chase - Temple Cancer Center
Philadelphia, Pennsylvania, 19140
United States
Ocala Oncology Center
Ocala, Florida, 34474
United States
Medical Oncology-Hematology Consultants, P.A.
Wilmington, Delaware, 19808
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
United States
Ocala Research Institute, Inc
Ocala, Florida, 34471
United States
Arlington-Fairfax Hematology/Oncology, PC
Arlington, Virginia, 22205
United States
North Penn Hospital
Lansdale, Pennsylvania, 19446-1200
United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
United States
Southwest Cancer Center at University Medical Center
Lubbock, Texas, 79415
United States
Medical Oncology Internal Medicine
Los Angeles, California, 90067
United States
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048
United States
St. John's Mercy Medical Center
St. Louis, Missouri, 63141
United States
Rockford Clinic
Rockford, Illinois, 61103
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Bay Area Tumor Institute
Oakland, California, 94609
United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, 75230
United States
Los Angeles County Harbor-UCLA Medical Center
Torrance, California, 90509
United States
Northwest Oncology and Hematology, S.C.
Elk Grove Village, Illinois, 60007
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Baptist Health System Cancer Program
San Antonio, Texas, 78205
United States
Akron General Medical Center
Akron, Ohio, 44302
United States
Dreyer Medical Clinic
Aurora, Illinois, 60506
United States
Hematology-Oncology Clinic
Baton Rouge, Louisiana, 70808
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Western Montana Clinic
Missoula, Montana, 59803
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Lone Star Oncology
Austin, Texas, 78759
United States
Cancer Care Center
New Albany, Indiana, 47150
United States
Additional Information:
Study ID Numbers: CDR0000068690; SANOFI-EFC3675
Study Start Date: July 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017459
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
3. Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
4. Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
5. Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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