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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Drug/Agent Toxicity by Tissue/Organ, Lung Cancer, Radiation Toxicity

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Dean L. McCarley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Veterans Affairs Medical Center - Gainesville

Authority:

United States: Federal Government

Study ID:

CDR0000066651

NCT ID:

NCT00003583

Start Date:

June 1997

Completion Date:

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Lung Cancer
  • Radiation Toxicity
  • limited stage small cell lung cancer
  • drug/agent toxicity by tissue/organ
  • radiation toxicity
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Radiation Injuries

Name

Location

University of Florida - GainesvilleGainesville, Florida  32610-0277