Amifostine in Treating Patients With Cancer Who Have Neurological Changes Caused by Chemotherapy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug/Agent Toxicity by Tissue/Organ; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: amifostine trihydrate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Rush North Shore Medical Center Official(s) and/or principal investigator(s):
Edward H. Kaplan, MD, Study Chair, Affiliation: Rush North Shore Medical Center
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 IV trial to study the effectiveness of amifostine in treating patients with
cancer who have neurological changes caused by chemotherapy.
Clinical Details
Official title: A Phase IV Open Label Study of the Effects of a Five Minute Infusion Time for Ethyol (Amifostine) in Patients Undergoing Chemotherapy
Study design: Supportive Care
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Rush North Shore Medical Center, Skokie, Illinois 60076, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 1997
Last updated: June 17, 2008
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