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Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Clinical research trials and Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer. Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer  Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as gemcitabine and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining tipifarnib with combination chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining tipifarnib with gemcitabine and cisplatin in treating patients who have stage III or stage IV non-small cell lung cancer.
Details: OBJECTIVES: - Determine the response rate of patients with stage IIIB or IV non-small cell lung cancer treated with tipifarnib, gemcitabine, and cisplatin. - Determine the efficacy of this regimen, in terms of time to disease progression, time to treatment failure, and survival, in these patients. - Determine the duration of response in patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Correlate polymorphism expression in candidate genes with clinical endpoints and toxicity in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral tipifarnib twice daily on days 1-14, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable disease may continue to receive oral tipifarnib alone twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer (NSCLC), meeting one of the following staging criteria: - Stage IIIB with pleural effusion - Stage IIIB and not a candidate for combination therapy with radiotherapy and chemotherapy - Stage IV - Measurable disease - At least one lesion at least 2.0 cm in diameter - No CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin greater than 10.0 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 5 times ULN - AST no greater than 3 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No New York Heart Association class III or IV heart disease - No known peripheral vascular disease - No history of deep vein thrombosis Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled infection - No other severe, underlying disease that would preclude study participation - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma - No grade 2 or greater preexisting peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy - No prior biologic therapy - No prior gene therapy Chemotherapy - See Disease Characteristics - No prior chemotherapy for NSCLC except therapy used as a radiosensitizer (i.e., low-dose weekly cisplatin and carboplatin/paclitaxel with radiotherapy) Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - See Chemotherapy - No prior radiotherapy to more than 25% of the bone marrow Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexAdjei, Study Chair, Mayo Clinic Cancer Center
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Howard University College of Medicine
Washington D.C., District of Columbia, 20059
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5589
United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, 49085
United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, 60201-1781
United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
United States
Michiana Hematology-Oncology, P.C. - South Bend
South Bend, Indiana, 46617
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Additional Information:
Study ID Numbers: CDR0000271196; NCI-5641,MAYO-MC0123
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055757
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed
2. Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
3. Lometrexol Plus Folic Acid in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
4. Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
5. Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
Related Studies:
Other stage 3B non-small cell lung cancer Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Tipifarnib, Gemcitabine, and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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