Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Supportive care, Treatment	Closed	Over 18	NCI, Other	CDR0000067523 WCCC-CO-9653, NCI-G00-1668, NCT00004264

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel, cisplatin, and amifostine in treating patients who have advanced non-small cell lung cancer that cannot be surgically removed.

Further Study Information

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.

Eligibility 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 injury

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Joan H. Schiller, MD

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00004264
Information obtained from ClinicalTrials.gov on September 29, 2009

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