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Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical research trials and Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer health trials occur in hundreds of cities 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer. Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer  Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB 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): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase II trial to study effectiveness of combining cisplatin, gemcitabine, and trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Details: OBJECTIVES: I. Determine the therapeutic efficacy and toxicity of cisplatin, gemcitabine, and trastuzumab (Herceptin) in patients with untreated p185-HER2 overexpressing stage IIIB or IV non-small cell lung cancer. II. Determine the pharmacokinetic interactions among these drugs in these patients. III. Assess the pharmacodynamics of these drugs in these patients. PROTOCOL OUTLINE: This is a multicenter study. Regimen A: Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 2 hours on day 1 and trastuzumab (Herceptin) IV over 90 minutes on day 2. Patients receive trastuzumab IV over 90 minutes followed by gemcitabine IV over 30 minutes on day 8 and trastuzumab IV over 90 minutes on day 15. Patients proceed to regimen B on day 22 of regimen A. Regimen B: Patients receive trastuzumab IV over 30-90 minutes, gemcitabine IV over 30 minutes, and cisplatin IV over 2 hours on day 1. Patients receive trastuzumab IV over 30-90 minutes followed by gemcitabine IV over 30 minutes on day 8 and trastuzumab IV over 30-90 minutes on day 15. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Maintenance: After completion of 6 courses, patients with stable disease or partial response receive trastuzumab IV over 30-90 minutes weekly until tumor progression. PROJECTED ACCRUAL: A total of 20-48 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-- - Immunohistochemically confirmed p185-HER2 expressing stage IIIB (pleural effusions only) or IV non-small cell lung cancer; Confirmed overexpression at least: 1+ p185-HER2 (by DAKO Hercep Test) OR 15 ng/mL serum HER2/neu shed antigen (by Human HER2 Quantitative ELISA) - At least 1 site of measurable disease outside of prior radiation port - Brain metastases allowed provided clinical neurologic status is stable and head CT scan is stable to improved --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 3 weeks since prior radiotherapy (including radiotherapy for brain metastases); No concurrent radiotherapy to only site of measurable disease - Surgery: At least 2 weeks since prior major surgery; No concurrent surgery on only site of measurable disease --Patient Characteristics-- - Age: Over 18 - Performance status: Zubrod 0-2 - Life expectancy: More than 12 weeks - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL (transfusion allowed) - Hepatic: Bilirubin less than 1.5 mg/dL; SGPT no greater than 1.5 times normal - Renal: Creatinine clearance at least 60 mL/min - Cardiovascular: No myocardial infarction within the past 6 months; No unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmia; Ejection fraction at least 40% - Other: No other malignancy within the past 5 years; No concurrent serious infection, including post-obstructive pneumonia; No more than 10% weight loss in past 3 months; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use adequate contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RoyHerbst, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000068626; MDA-DM-99015,NCI-4450
Study Start Date: May 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016367
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
3. Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
4. 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
5. Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Related Studies:
Other stage 3B non-small cell lung cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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