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Phase I/II Trial of Amifostine, High-Dose Cisplatin and Docetaxel in Patients With Advanced Lung Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Drug/Agent Toxicity by Tissue/Organ, Lung Cancer

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Trial Information

Phase I/II Trial of Amifostine, High-Dose Cisplatin and Docetaxel in Patients With Advanced Lung Cancer

OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel when combined with
amifostine and high dose cisplatin in patients with advanced non-small cell lung cancer. II.
Determine the response rate and survival of these patients treated with this regimen. III.
Determine the tolerability of this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study of docetaxel. Patients receive
amifostine IV over 15 minutes, immediately followed by docetaxel IV over 1 hour, followed at
hour 2 by amifostine as above, immediately followed by high dose cisplatin IV over 30
minutes. Treatment repeats every 4 weeks in the absence of disease progression or
unacceptable toxicity. Cohorts of patients receive escalating doses of docetaxel until the
maximum tolerated dose is determined.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven unresectable advanced non-small cell lung
cancer Stable CNS metastases allowed

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0 or 1 Life expectancy: Not
specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least
2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 2.5 times upper
limit of normal (ULN) AND alkaline phosphatase no greater than ULN OR AST no greater than
ULN AND alkaline phosphatase no greater than 4 times ULN Renal: Creatinine clearance at
least 60 mL/min Other: Not pregnant Fertile patients must use effective contraception No
peripheral neuropathy worse than grade 1

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Any type and any
number of prior chemotherapy regimens allowed and recovered Greater than 3 months since
prior cisplatin and recovered Endocrine therapy: Prior endocrine therapy allowed and
recovered Radiotherapy: Prior radiotherapy allowed and recovered Surgery: Prior surgery
allowed and recovered Other: No other concurrent medications which could cause renal

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Joan H. Schiller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Federal Government

Study ID:




Start Date:

July 1997

Completion Date:

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • drug/agent toxicity by tissue/organ
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792