Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003128
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
1999-11-01
Brief Title:
Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced Refractory or Recurrent Cancer of the Uterus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase III Trial of Ifosfamide NSC 109274 Versus Ifosfamide Plus Paclitaxel NSC 125973 in Patients With Advanced Persistent or Recurrent Carcinosarcoma Mixed Mesodermal Tumors of the Uterus
Status:
COMPLETED
Status Verified Date:
2004-05
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 It is not yet known whether ifosfamide alone is more effective than ifosfamide plus paclitaxel in treating patients with cancer of the uterus
PURPOSE Randomized phase III trial to compare the effectiveness of ifosfamide with or without paclitaxel in treating patients with advanced refractory or recurrent cancer of the uterus
PURPOSE Randomized phase III trial to compare the effectiveness of ifosfamide with or without paclitaxel in treating patients with advanced refractory or recurrent cancer of the uterus
Detailed Description:
OBJECTIVES
Determine whether the addition of paclitaxel to ifosfamide improves length of survival progression free interval and response rate when compared to ifosfamide alone in patients with advanced refractory or recurrent carcinosarcoma mixed mesodermal tumors of the uterus
Determine the toxicity of ifosfamide with paclitaxel in these patients
OUTLINE This is a randomized study Patients are stratified according to GOG performance status GOG 0-1 vs GOG 2-3 and randomized to one of two treatment arms
Arm I Patients receive ifosfamide IV daily for 3 days every 21 days
Arm II Patients receive paclitaxel IV on day 1 and ifosfamide IV on days 1-3 every 21 days Filgrastim G-CSF is given subcutaneously beginning on day 4 until granulocyte count is greater than 2000mm3 Paclitaxel therapy may precede or be given concurrently with ifosfamide
Treatment for both arms continues for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years then every 6 months for an additional 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 166 patients 83 per arm will be accrued for this study within approximately 55 years
Determine whether the addition of paclitaxel to ifosfamide improves length of survival progression free interval and response rate when compared to ifosfamide alone in patients with advanced refractory or recurrent carcinosarcoma mixed mesodermal tumors of the uterus
Determine the toxicity of ifosfamide with paclitaxel in these patients
OUTLINE This is a randomized study Patients are stratified according to GOG performance status GOG 0-1 vs GOG 2-3 and randomized to one of two treatment arms
Arm I Patients receive ifosfamide IV daily for 3 days every 21 days
Arm II Patients receive paclitaxel IV on day 1 and ifosfamide IV on days 1-3 every 21 days Filgrastim G-CSF is given subcutaneously beginning on day 4 until granulocyte count is greater than 2000mm3 Paclitaxel therapy may precede or be given concurrently with ifosfamide
Treatment for both arms continues for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years then every 6 months for an additional 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 166 patients 83 per arm will be accrued for this study within approximately 55 years
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 |
|---|---|---|---|
| ECOG-G0161 | None | None | None |
| GOG-0161 | None | None | None |