Trial | NCT00158041  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    amifostine ...

  • Study Participants

    452
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.
Study Started
Jan 31
2002
Study Completion
Jan 31
2005
Last Update
Sep 12
2005
Estimate

Drug Amifostine administered subcutaneously

Criteria 

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
No Results Posted