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

Primary Purpose

Drug/Agent Toxicity by Tissue/Organ, Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
amifostine trihydrate
cisplatin
docetaxel
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug/Agent Toxicity by Tissue/Organ focused on measuring recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, drug/agent toxicity by tissue/organ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 28, 2000
Last Updated
December 3, 2013
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004264
Brief Title
Docetaxel, Cisplatin, and Amifostine in Treating Patients With Advanced Non-small Cell Lung Cancer
Official Title
Phase I/II Trial of Amifostine, High-Dose Cisplatin and Docetaxel in Patients With Advanced Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2000
Overall Recruitment Status
Unknown status
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug/Agent Toxicity by Tissue/Organ, Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, drug/agent toxicity by tissue/organ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
amifostine trihydrate
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan H. Schiller, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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