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.

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. 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.

Ages Eligible for Study:  18 Years and above

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

Colorado
      Rocky Mountain Cancer Center, Denver,  Colorado,  80218,  United States
Missouri
      Washington University Barnard Cancer Center, Saint Louis,  Missouri,  63110,  United States
North Carolina
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Pennsylvania
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213,  United States

Study chairs or principal investigators

Todd H. Wasserman,  Study Chair,  Washington University Barnard Cancer Center   

Study ID Numbers:  CDR0000067202; WU-98-0206; NCI-V99-1559; ALZA-WU-98-0206
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  January 21, 2000
ClinicalTrials.gov Identifier:  NCT00004176
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08