NCT00601198

A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer

Phase II Study of the Efficacy of Amifostine (Ethyol) in Reducing the Incidence and Severity of Oxaliplatin-Induced Neuropathy in Patients With Colorectal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effect of amifostine (ETHYOL) on decreasing the rate and severity of nerve dysfunction or neuropathy (numbness and tingling in hands and feet) associated with FOLFOX chemotherapy.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Amifostine	Patients should be treated with oxaliplatin-based chemotherapy in combination with amifostine for 12 cycles, or until unacceptable toxicity is observed or disease progression

Timeline

• Start date: 2006-10-01
• Primary completion: 2010-01-13
• Completion: 2010-01-13
• First posted: 2008-01-25
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

1 site across 1 country: United States