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Phase IV Study of Amifostine for Chemotherapy Induced Peripheral Neuropathy in Patients with Cancer (Summary Last Modified 04/2000)

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

Alternate Title

Amifostine in Treating Patients With Cancer Who Have Neurological Changes Caused by Chemotherapy

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase IV Supportive care Completed 18 and over Pharmaceutical / Industry RNSMC-AM9702
ALZA-RNSMC-AM9702, NCI-V98-1390, NCT00003252

Objectives

I. Determine the feasibility and tolerability of administering amifostine by 
intravenous infusion over 5 minutes in cancer patients undergoing chemotherapy.

Entry Criteria

Disease Characteristics:


Histologically or cytologically proven cancer

No brain or other CNS metastases (including prior treated metastases)

Prior/Concurrent Therapy:


Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 No prior estrogen within 24 hours of amifostine therapy

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 No prior alcohol, disulphiram, tetracycline, or erythromycin within 24 hours
  of amifostine therapy
 No prior antiemetics such as benzodiazepines, antipsychotics,
  anticonvulsants, or antihistamines within 24 hours of amifostine therapy

Patient Characteristics:


Age:
 18 and over

Performance Status:
 ECOG 0-1

Life Expectancy:
 Not specified

Hematopoietic:
 Not specified
 
Hepatic:
 No grade 3 or greater hepatic dysfunction
 
Renal:
 No hypercalcemia

Cardiovascular:
 No uncontrolled hypotension

Other:
 Not pregnant or nursing
 Effective contraceptive method must be used by fertile patients
 No psychosis
 No severe concurrent illness other than neoplasia
 No epileptic seizures during the previous year, migraines, gastrointestinal
  obstructions, or other causes of vomiting
 No prior or concurrent amifostine contraindications
 No prior known contraindications or sensitivity to dexamethasone,
  granisetron, ondansetron, prochlorperazine, diphenhydramine, cimetidine, or
  magnesium

Expected Enrollment

 A total of 20 patients will be accrued for this study.

Outline

This is an open label, controlled study.

Patients receive intravenous amifostine over 5 minutes 30 minutes prior to 
chemotherapy.

Patients are followed for one month post treatment.

Trial Contact Information

Trial Lead Organizations

Rush North Shore Medical Center

Edward Kaplan, MD, Protocol chair
Ph: 847-677-9600
Email: ekap@dnamail.com

Registry Information

Official Title		A Phase IV Open Label Study of the Effects of a Five Minute Infusion Time for Ethyol (Amifostine) in Patients Undergoing Chemotherapy

Trial Start Date		1997-12-01

Registered in ClinicalTrials.gov		NCT00003252

Date Submitted to PDQ		1998-03-06

Information Last Verified		2000-04-01

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.