Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058071
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
2003-04-07
Brief Title:
Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Phase III Trial of Amifostine vs No Treatment for Platinum Induced Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Amifostine may be effective in relieving numbness tingling and other symptoms of peripheral neuropathy It is not yet known whether amifostine is effective in treating peripheral neuropathy in patients who have received chemotherapy for cancer
PURPOSE This randomized phase III trial is studying amifostine to see how well it works compared to observation in relieving numbness tingling and other symptoms of peripheral neuropathy in patients who have received platinum-based chemotherapy such as cisplatin or carboplatin for cancer
PURPOSE This randomized phase III trial is studying amifostine to see how well it works compared to observation in relieving numbness tingling and other symptoms of peripheral neuropathy in patients who have received platinum-based chemotherapy such as cisplatin or carboplatin for cancer
Detailed Description:
OBJECTIVES
Determine preliminarily whether amifostine is superior to no treatment in terms of improving the symptoms andor objective findings of platinum-induced peripheral neuropathy in patients with cancer
Determine the toxicity of this drug in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive amifostine IV or subcutaneously over 3 minutes on days 1 3 and 5 Treatment continues for 12 weeks in the absence of unacceptable toxicity Patients are observed for 12 weeks
Arm II Patients are observed for 24 weeks After 24 weeks patients may cross over to treatment as in arm I
Quality of life is assessed at baseline and then at 6 12 18 and 24 weeks after study entry
Patients are followed at 6 and 12 weeks after study treatment every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 50-100 patients 25-50 per treatment arm will be accrued for this study
Determine preliminarily whether amifostine is superior to no treatment in terms of improving the symptoms andor objective findings of platinum-induced peripheral neuropathy in patients with cancer
Determine the toxicity of this drug in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive amifostine IV or subcutaneously over 3 minutes on days 1 3 and 5 Treatment continues for 12 weeks in the absence of unacceptable toxicity Patients are observed for 12 weeks
Arm II Patients are observed for 24 weeks After 24 weeks patients may cross over to treatment as in arm I
Quality of life is assessed at baseline and then at 6 12 18 and 24 weeks after study entry
Patients are followed at 6 and 12 weeks after study treatment every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 50-100 patients 25-50 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-0192 | None | None | None |