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.

Condition	Treatment or Intervention	Phase
limited stage small cell lung cancer Drug Toxicity radiation toxicity	Drug: amifostine  Drug: cisplatin  Drug: etoposide	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

Florida
      University of Florida - Gainesville, Gainesville,  Florida,  32610-0277,  United States

Study chairs or principal investigators

Dean Latain McCarley,  Study Chair,  University of Florida   

Study ID Numbers:  CDR0000066651; UF-G-97120405; NCI-V98-1475; ALZA-97-033-ii
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003583
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08