Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Radiation Toxicity
Intervention: amifostine trihydrate (Drug); cisplatin (Drug); etoposide (Drug); radiation therapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Florida Official(s) and/or principal investigator(s):
Dean L. McCarley, MD, Study Chair, Affiliation: Veterans Affairs Medical Center - Gainesville
Summary
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.
Clinical Details
Official title: A Phase II Trial Using Amifostine as a Chemo/Radio Protective Agent in the Treatment of Limited Stage Small-Cell Lung Cancer
Study design: Supportive Care
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Florida - Gainesville, Gainesville, Florida 32610-0277, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 1997
Last updated: June 17, 2008
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