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Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer Clinical research trials and Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer. Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer  Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer
Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer
For Condition: radiation toxicity,Drug Toxicity,limited stage small cell lung cancer
Status: No longer recruiting
Sponsor(s): University of Florida ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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 to prevent side effects in patients who are receiving chemotherapy and radiation therapy for limited-stage small cell lung cancer.
Details: OBJECTIVES: I. Evaluate the reduction in toxicities by combining amifostine with cisplatin, etoposide, and radiotherapy in patients with limited stage small cell lung cancer. II. Evaluate the response rate to this combination by these patients. III. Evaluate the overall survival of patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients receive cisplatin IV on day 1 and etoposide IV daily on days 1-3. This course is repeated every 3 weeks for a total for 4 courses. Patients also receive concurrent radiotherapy 5 days per week for 5.5 weeks starting with the first course of chemotherapy. Patients receive amifostine IV over 15 minutes 15-30 minutes prior to each dose of chemotherapy on days 1-3. Patients are followed at 6 and 12 weeks, then every 3 months for 9 months, every 6 months for 1 year, and then until death. PROJECTED ACCRUAL: There will be 20 patients accrued into this study.
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 - Primary tumor must be evaluable radiographically --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-1 - Life expectancy: At least 3 months - Hematopoietic: WBC greater than 4,000/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 2 times normal - Renal: Creatinine less than 1.5 mg/dL - Other: No concurrent active infection; No prior malignancy except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix; Not pregnant or nursing; Effective contraception required of all fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeanMcCarley, Study Chair, University of Florida
University of Florida - Gainesville
Gainesville, Florida, 32610-0277
United States
Additional Information:
Study ID Numbers: CDR0000066651; UF-G-97120405,NCI-V98-1475,ALZA-97-033-ii
Study Start Date: June 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003583
Other Limited Stage Small Cell Lung Cancer Studies:
1. Radiation Therapy and Cisplatin With or Without Amifostine in Treating Patients With Stage IIIB or Stage IVA Cancer of the Cervix
2. Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus
3. Melatonin and Radiation Therapy in Treating Patients With Brain Metastases
4. Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
5. Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx
Related Studies:
Other limited stage small cell lung cancer Clinical Trials
Other Florida Clinical Trials
Other Gainesville Clinical Trials
Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer
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