Phase II Study of the Efficacy of Amifostine (Ethyol) in Reducing the Incidence and Severity of Oxaliplatin-Induced Neuropathy in Patients With Colorectal Cancer
In addition, this study will provide information on how subjects with colorectal cancer do
while receiving amifostine in combination with other chemotherapy drugs. This study will
also look at the frequency of complications associated with amifostine and chemotherapy.
The FOLFOX chemotherapy regimen consists of three drugs, 5-FU, leucovorin, and oxaliplatin,
all given intravenously (into the vein) every 2 weeks with or without Avastin given in
combination with chemotherapy. FOLFOX has been approved by the Food and Drug Administration
(FDA) for the treatment of cancer of the colon or rectum.
Amifostine is not a chemotherapy drug. It is approved by the Food and Drug Administration
(FDA) to prevent moderate or severe dryness of the mouth caused by radiation treatment for
head and neck cancer, and to prevent kidney damage caused by cisplatin chemotherapy
treatment for ovarian and non-small cell lung cancer. Amifostine is not FDA approved for use
in this study and is therefore considered investigational.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Test drug in 28 patients. Trial will be terminated if 5 or more have grade 3 & 4 PSN. Will continue & add patients if 4 or fewer patients with grade 3 & 4 toxicity out of 28.
Leslie Oleksowicz, MD
University of Cincinnati
United States: Institutional Review Board
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