Ignite Creation Date:
2024-05-05 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 9:42 AM
Study NCT ID:
NCT00601198
Status:
TERMINATED
Last Update Posted:
2023-08-01
First Post:
2008-01-14
Brief Title:
A Study of Amifostine Ethyol in Patients With Colorectal Cancer
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
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
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding support withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ETH190-06 | None | None | None |