Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004166
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
1999-12-10
Brief Title:
Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Amifostine as a Toxicity Protectant in Ovarian Cancer in Chemotherapy Treated Patients A Pilot Phase III Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2012-05
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Randomized phase III trial to study the effectiveness of amifostine in treating patients who have ovarian epithelial cancer and who are receiving chemotherapy
PURPOSE Randomized phase III trial to study the effectiveness of amifostine in treating patients who have ovarian epithelial cancer and who are receiving chemotherapy
Detailed Description:
OBJECTIVES I Determine if patients with ovarian epithelial cancer receiving chemotherapy have significantly fewer neurologic events when treated with amifostine II Compare amifostine vs no chemoprotection in terms of overall incidence of neuropathy incidence of neutropenia infection and other myelosuppressive events eg leukopenia anemia and thrombocytopenia length of hospital stay due to infections and quality of life in this patient population
OUTLINE This is a randomized parallel controlled double blind study Patients are randomized to one of two treatment arms Arm I Patients receive amifostine IV over 10 minutes 30 minutes prior to chemotherapy Arm II Patients receive a placebo IV over 10 minutes 30 minutes prior to chemotherapy Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed prior to courses 1 4 and 8 and then every 3 months for 1 year Patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 2 years
OUTLINE This is a randomized parallel controlled double blind study Patients are randomized to one of two treatment arms Arm I Patients receive amifostine IV over 10 minutes 30 minutes prior to chemotherapy Arm II Patients receive a placebo IV over 10 minutes 30 minutes prior to chemotherapy Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed prior to courses 1 4 and 8 and then every 3 months for 1 year Patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| NCI-G99-1633 | None | None | None |
| NU-97CC4 | None | None | None |