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Docetaxel, Cisplatin, and Amifostine in Treating Patients With Advanced Non-small Cell Lung Cancer

NCT ID: NCT00004264

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1997-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Drug/Agent Toxicity by Tissue/Organ Lung Cancer

Keywords

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recurrent non-small cell lung cancer stage IV non-small cell lung cancer drug/agent toxicity by tissue/organ

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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amifostine trihydrate

Intervention Type DRUG

cisplatin

Intervention Type DRUG

docetaxel

Intervention Type DRUG

Eligibility Criteria

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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 injury
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Principal Investigators

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Joan H. Schiller, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

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University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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WCCC-CO-9653

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1668

Identifier Type: -

Identifier Source: secondary_id

CDR0000067523

Identifier Type: -

Identifier Source: org_study_id