Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003624
Status:
TERMINATED
Last Update Posted:
2013-04-11
First Post:
1999-11-01
Brief Title:
Amifostine in Treating Women With Ovarian Peritoneal Cervical Fallopian Tube Uterine or Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Limited Access Trial Using Amifostine for Protection Against Cisplatin and 3-Hour Paclitaxel-Induced Neurotoxicity
Status:
TERMINATED
Status Verified Date:
2006-05
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 Phase II trial to study the effectiveness of amifostine in reducing the risk of side effects caused by cisplatin and paclitaxel in treating women who have ovarian peritoneal cervical fallopian tube uterine or endometrial cancer
PURPOSE Phase II trial to study the effectiveness of amifostine in reducing the risk of side effects caused by cisplatin and paclitaxel in treating women who have ovarian peritoneal cervical fallopian tube uterine or endometrial cancer
Detailed Description:
OBJECTIVES I Determine the efficacy of amifostine in reducing significant peripheral neuropathy in women with ovarian peritoneal cervical fallopian tube uterine or endometrial cancer treated with cisplatin and paclitaxel II Determine the proportion of patients on this regimen who experience significant peripheral neuropathy 3 months after completing chemotherapy III Assess the overall toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 3 hours amifostine IV over 10 minutes and cisplatin IV over 90 minutes Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Neurotoxicity is assessed and vibration perception threshold testing is performed prior to each course of chemotherapy and at 3 months following the last treatment Patients are followed every 3 months for 2 years then every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 29-59 patients will be accrued for this study within 18-36 months
OUTLINE Patients receive paclitaxel IV over 3 hours amifostine IV over 10 minutes and cisplatin IV over 90 minutes Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Neurotoxicity is assessed and vibration perception threshold testing is performed prior to each course of chemotherapy and at 3 months following the last treatment Patients are followed every 3 months for 2 years then every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 29-59 patients will be accrued for this study within 18-36 months
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 |
|---|---|---|---|
| GOG-9805 | None | None | None |