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Phase II Chemoprotective Study of Amifostine in Combination with Paclitaxel and Carboplatin in Patients with Metastatic Ovarian and Non-Small Cell Lung Cancer (Summary Last Modified 02/2000)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With Metastatic Ovarian Cancer or Non-small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Supportive care, Treatment Closed 18 and over Pharmaceutical / Industry UCSF-H57841348101A
ALZA-UCSF-H57841348101A, NCI-V97-1334, NCT00003072

Objectives

I. Determine whether patients with metastatic ovarian and non-small cell lung 
cancer receiving carboplatin and paclitaxel have significantly fewer 
neuropathic events when treated with amifostine.

Entry Criteria

Disease Characteristics:


Histologically proven stage III/IV ovarian or non-small cell lung cancer

Prior/Concurrent Therapy:


Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy within 1 month of study
 
Endocrine therapy:
 Not specified

Radiotherapy:
 No prior radiation therapy within 1 month of study

Surgery:
 Not specified

Patient Characteristics:

 
Age:
 18 and over

Performance Status:
 ECOG 0-2

Life Expectancy:
 Not specified
 
Hematopoietic:
 Absolute neutrophil count at least 1,500/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Bilirubin no greater than 3.0 mg/dL

Renal:
 Creatinine no greater than 2 mg/dL

Other:
 Not pregnant or nursing
 No history of platinum, paclitaxel or amifostine hypersensitivity
 Prior myelosuppressive events allowed
 No clinically significant ascites

Expected Enrollment

A total of 80 patients will be accrued (40 with advanced ovarian cancer and 40 
with advanced non-small cell lung cancer) within 2 years.

Outline

This is a randomized, parallel group, double blind, controlled study.

Patients are randomized to either the amifostine or control group. All 
patients receive intravenous paclitaxel over 3 hours, followed by carboplatin 
once every 3 weeks for 6 cycles.

Patients who are randomized to the amifostine group receive intravenous 
amifostine administered as a 15 minute infusion 30 minutes prior to paclitaxel 
therapy. Patients randomized to the control group receive an intravenous 
placebo solution.

Patients are discontinued from the study if they have disease progression or 
unacceptable toxic effects after 2 cycles of treatment.

Patients are followed monthly for 8 months post treatment.

Trial Contact Information

Trial Lead Organizations

UCSF Helen Diller Family Comprehensive Cancer Center

Robert Ignoffo, PharmD, Protocol chair
Ph: 415-567-6600; 800-888-8664

Registry Information

Official Title		Amifostine (Ethyol) as a Protectant in Metastatic Ovarian and Non-Small Cell Lung Cancer in Paclitaxel/Carboplatin-Treated Patients: A Comparative Trial

Trial Start Date		1997-05-28

Registered in ClinicalTrials.gov		NCT00003072

Date Submitted to PDQ		1997-09-03

Information Last Verified		2006-05-19

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.