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.

Condition	Treatment or Intervention	Phase
Drug Toxicity stage IV non-small cell lung cancer recurrent non-small cell lung cancer	Drug: amifostine  Drug: cisplatin  Drug: docetaxel	Phase I Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven unresectable advanced non-small cell lung cancer
• Stable CNS metastases allowed

--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

--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

Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States

Study chairs or principal investigators

Joan Hoff Schiller,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   

Study ID Numbers:  CDR0000067523; WCCC-CO-9653; NCI-G00-1668
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  January 28, 2000
ClinicalTrials.gov Identifier:  NCT00004264
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08