Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Closed	18 and over	Pharmaceutical / Industry	WU-98-0206 ALZA-WU-98-0206, NCI-V99-1559, NCT00004176

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.

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

Expected Enrollment

Approximately 33 patients will be accrued for this study within 1-2 years.

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. 

Trial Contact Information

Trial Lead Organizations

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Todd Wasserman, MD, Protocol chair(Contact information may not be current)		Ph: 314-454-7236; 800-600-3606

Registry Information
Official Title		A Phase II Evaluation of Ethyol as an Esophageal Mucosal Protectant in the Treatment of Limited Disease Small Cell Lung Cancer with Chemotherapy and Twice-Daily Radiation
Trial Start Date		1998-08-19
Registered in ClinicalTrials.gov		NCT00004176
Date Submitted to PDQ		1999-07-21
Information Last Verified		2006-05-18

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