Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer
This trial is active, not recruiting.
|Conditions||drug/agent toxicity by tissue/organ, lung cancer, radiation toxicity|
|Treatments||amifostine trihydrate, cisplatin, etoposide, radiation therapy|
|Sponsor||University of Florida|
|Start date||June 1997|
|Trial size||20 participants|
|Trial identifier||NCT00003583, ALZA-97-033-ii, CDR0000066651, NCI-V98-1475, UF-G-97120405|
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.
|Primary purpose||supportive care|
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: Histologically confirmed limited stage small cell lung cancer Primary tumor must be evaluable radiographically 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 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
|Official title||A Phase II Trial Using Amifostine as a Chemo/Radio Protective Agent in the Treatment of Limited Stage Small-Cell Lung Cancer|
|Description||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. 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.|
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