Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003945
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
1999-11-01
Brief Title:
Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB Recurrent or Persistent Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Phase III Study of Cisplatin Versus Cisplatin Plus Topotecan Versus MVAC in Stage IVB Recurrent or Persistent Squamous Cell Carcinoma of the Cervix
Status:
COMPLETED
Status Verified Date:
2004-09
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 tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known which chemotherapy regimen is more effective for cervical cancer
PURPOSE Randomized phase III trial to compare the effectiveness of three different chemotherapy regimens in treating patients with stage IVB recurrent or persistent cervical cancer
PURPOSE Randomized phase III trial to compare the effectiveness of three different chemotherapy regimens in treating patients with stage IVB recurrent or persistent cervical cancer
Detailed Description:
OBJECTIVES
Compare the response rate and survival of patients with stage IVB recurrent or persistent carcinoma of the cervix treated with cisplatin only vs cisplatin plus topotecan vs methotrexate vinblastine doxorubicin and cisplatin MVAC Arm III MVAC closed to accrual effective 07232001
Compare the toxic effects of these regimens in this patient population
Compare health-related quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to GOG performance status Patients are randomized to one of three treatment arms Arm III closed to accrual effective 07232001
Arm I Patients receive cisplatin IV once every 21 days
Arm IIPatients receive topotecan IV over 30 minutes on days 1-3 and cisplatin IV beginning after topotecan infusion on day 1 Courses repeat every 21 days
Arm IIIPatients receive methotrexate IV on days 1 15 and 22 vinblastine IV on days 2 15 and 22 and doxorubicin IV and cisplatin IV on day 2 Courses repeat every 28 days Arm III closed to accrual effective 07232001 Treatment in all arms continues for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Arm III closed to accrual effective 07232001
Quality of life is assessed before randomization before course 2 before course 5 arms I and II before course 4 arm III and at 9 months Arm III closed to accrual effective 07232001
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 400 patients 133 per treatment arm will be accrued for this study within 2 years Arm III closed to accrual effective 07232001
Compare the response rate and survival of patients with stage IVB recurrent or persistent carcinoma of the cervix treated with cisplatin only vs cisplatin plus topotecan vs methotrexate vinblastine doxorubicin and cisplatin MVAC Arm III MVAC closed to accrual effective 07232001
Compare the toxic effects of these regimens in this patient population
Compare health-related quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to GOG performance status Patients are randomized to one of three treatment arms Arm III closed to accrual effective 07232001
Arm I Patients receive cisplatin IV once every 21 days
Arm IIPatients receive topotecan IV over 30 minutes on days 1-3 and cisplatin IV beginning after topotecan infusion on day 1 Courses repeat every 21 days
Arm IIIPatients receive methotrexate IV on days 1 15 and 22 vinblastine IV on days 2 15 and 22 and doxorubicin IV and cisplatin IV on day 2 Courses repeat every 28 days Arm III closed to accrual effective 07232001 Treatment in all arms continues for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Arm III closed to accrual effective 07232001
Quality of life is assessed before randomization before course 2 before course 5 arms I and II before course 4 arm III and at 9 months Arm III closed to accrual effective 07232001
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 400 patients 133 per treatment arm will be accrued for this study within 2 years Arm III closed to accrual effective 07232001
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-G0179 | None | None | None |
| GOG-0179 | None | None | None |