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Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage 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 Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical research trials and Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage 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 Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer. Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage 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 Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage 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 > "A" Clinical Trials Conditions > Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer  Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
For Condition: radiation toxicity,limited stage small cell lung cancer,Drug Toxicity
Status: No longer recruiting
Sponsor(s): Washington University Barnard Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy. PURPOSE: Phase II trial to study the effectiveness of amifostine plus chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.
Details: OBJECTIVES: I. Determine the incidence and duration of moderate and severe acute esophagitis in patients with limited stage small cell lung cancer treated with amifostine chemoprotection plus chemotherapy and radiotherapy. II. Determine the tumor response to this regimen in these patients. PROTOCOL OUTLINE: Course 1: Patients receive amifostine IV over 5 minutes daily, followed by radiotherapy twice daily Monday through Friday for 3 weeks. Patients receive cisplatin IV over 30-60 minutes on day 1, and etoposide IV over 1 hour on days 1, 2, and 3. Courses 2-4: Patients receive amifostine over 15 minutes on day 1, followed by cisplatin IV over 30-60 minutes and etoposide IV over 1 hour every 3 weeks. Patients are followed at 1 month, then every 3 months until death. PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed limited stage small cell lung cancer confined to one hemithorax - Measurable disease - No pleural effusion(s) --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic therapy - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: Not specified - Other: No drugs that could potentiate nephrotoxicity of cisplatin (e.g., aminoglycosides or lithium) --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 75,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT and alkaline phosphatase no greater than 2 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min; Calcium normal (8.9-10.3 mg/dL) - Cardiovascular: No history of congestive heart failure or myocardial infarction within the past 6 months; No uncontrolled or unexplained rhythm disturbance or symptoms of unstable ischemic heart disease - Other: Not pregnant; Fertile patients must use effective contraception; No prior or concurrent malignancy within the past 5 years, except: Basal or squamous cell skin cancer; Carcinoma in situ of the cervix; No concurrent infection; No significant uncontrolled hyponatremia; No other significant concurrent medical or psychiatric illness which would preclude compliance; No antecedent hearing loss; Afebrile for at least 3 days unless fever due to tumor or obstructive pneumonia
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ToddWasserman, Study Chair, Washington University Barnard Cancer Center
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Washington University Barnard Cancer Center
St. Louis, Missouri, 63110
United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Additional Information:
Study ID Numbers: CDR0000067202; WU-98-0206,NCI-V99-1559,ALZA-WU-98-0206
Study Start Date: August 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004176
Other Limited Stage Small Cell Lung Cancer Studies:
1. Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer
2. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer
3. Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
4. Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer
5. Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy
Related Studies:
Other limited stage small cell lung cancer Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
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