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| Sponsor: | Rush North Shore Medical Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003252 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Unspecified Adult Solid Tumor, Protocol Specific |
Drug: amifostine trihydrate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| 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 Start Date: | December 1997 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| Rush North Shore Medical Center | |
| Skokie, Illinois, United States, 60076 | |
| Study Chair: | Edward H. Kaplan, MD | Rush North Shore Medical Center |
More Information
| Study ID Numbers: | CDR0000066134, RNSMC-AM9702, ALZA-RNSMC-AM9702, NCI-V98-1390 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003252 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific drug/agent toxicity by tissue/organ |
|
Radiation-Protective Agents Amifostine Physiological Effects of Drugs Protective Agents Pharmacologic Actions |
