Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003691
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III Stage IV or Recurrent Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III IV or Recurrent Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2010-09
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III stage IV or recurrent endometrial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III stage IV or recurrent endometrial cancer
Detailed Description:
OBJECTIVES
Determine whether the addition of paclitaxel using filgrastim G-CSF support to standard doxorubicincisplatin chemotherapy produces improvement in the frequency of objective response progression-free survival or overall survival in patients with stage III stage IV or recurrent endometrial carcinoma
Compare the toxicities of these two regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin IV over 15-30 minutes followed immediately by cisplatin IV over 1 hour
Arm II Patients receive doxorubicin and cisplatin as in arm I on day 1 On day 2 patients receive paclitaxel IV over 3 hours Patients also receive filgrastim G-CSF subcutaneously beginning on day 3 and continuing for at least 10 days
Courses are repeated every 21 days Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 240 patients 120 per arm will be accrued for this study within 21 months
Determine whether the addition of paclitaxel using filgrastim G-CSF support to standard doxorubicincisplatin chemotherapy produces improvement in the frequency of objective response progression-free survival or overall survival in patients with stage III stage IV or recurrent endometrial carcinoma
Compare the toxicities of these two regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin IV over 15-30 minutes followed immediately by cisplatin IV over 1 hour
Arm II Patients receive doxorubicin and cisplatin as in arm I on day 1 On day 2 patients receive paclitaxel IV over 3 hours Patients also receive filgrastim G-CSF subcutaneously beginning on day 3 and continuing for at least 10 days
Courses are repeated every 21 days Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 240 patients 120 per arm will be accrued for this study within 21 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-0177 | None | None | None |