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


Phase 4
18 Years
N/A
Not Enrolling
Both
Drug/Agent Toxicity by Tissue/Organ, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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

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.

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

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically proven cancer No brain or other
CNS metastases (including prior treated metastases)

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Edward H. Kaplan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rush North Shore Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000066134

NCT ID:

NCT00003252

Start Date:

December 1997

Completion Date:

September 2004

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • drug/agent toxicity by tissue/organ

Name

Location

Rush North Shore Medical CenterSkokie, Illinois  60076