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Phase II Study of Amifostine as a Chemo/Radio Protective Agent in Patients with Limited Stage Small Cell Lung Cancer Receiving Cisplatin, Etoposide, and Radiotherapy

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

Alternate Title

Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Supportive care, Treatment Closed Over 18 Pharmaceutical / Industry UF-G-97120405
ALZA-97-033-ii, NCI-V98-1475, NCT00003583

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.

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

Expected Enrollment

There will be 20 patients accrued into this study.

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.

Trial Contact Information

Trial Lead Organizations

University of Florida Shands Cancer Center

Dean McCarley, MD, Protocol chair
Ph: 352-374-6016; 800-324-8387

Registry Information

Official Title		A Phase II Trial Using Amifostine as a Chemo/Radio Protective Agent in the Treatment of Limited Stage Small-Cell Lung Cancer

Trial Start Date		1997-06-01

Registered in ClinicalTrials.gov		NCT00003583

Date Submitted to PDQ		1998-09-15

Information Last Verified		2006-05-18

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.