Docetaxel, Cisplatin, and Amifostine in Treating Patients With Advanced Non-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
Intervention: amifostine trihydrate (Drug); cisplatin (Drug); docetaxel (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s):
Joan H. Schiller, MD, Study Chair, Affiliation: University of Wisconsin, Madison
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.
Clinical Details
Official title: Phase I/II Trial of Amifostine, High-Dose Cisplatin and Docetaxel in Patients With Advanced Lung Cancer
Study design: Treatment
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 1997
Last updated: June 17, 2008
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