Subcutaneous Amifostine Safety Study

Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.

Inclusion Criteria:

• Institutional criteria for administration of amifostine
• Radiation therapy
• ECOG PS of at least 2
• No distant mets
• Granulocyte count greater than 2000
• Platelet count greater than 100,000
• Creatinine less than 2.0

Exclusion Criteria:

• Allergy to amifostine
• Life expectancy less than 6 mos
• Investigational drug within last 4 weeks