Expired Study
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Madison, Wisconsin 53792


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.

Study summary:

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.


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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

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

Overall Status:

Active, not recruiting

Study Phase:

Phase 1/Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Joan H. Schiller, MD
Study Chair
University of Wisconsin, Madison

Study Dates

Start Date:July 1997
Verification Date:August 2000
Last Changed Date:December 3, 2013
First Received Date:January 28, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:amifostine trihydrate
Intervention Type:Drug
Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Wisconsin, Madison
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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