Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064077
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2003-07-08
Brief Title:
Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB Recurrent or Persistent Cancer of the Cervix
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB Recurrent Or Persistent Carcinoma of the Cervix
Status:
COMPLETED
Status Verified Date:
2018-08
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:
This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB recurrent or persistent cancer of the cervix Drugs used in chemotherapy such as cisplatin paclitaxel vinorelbine gemcitabine and topotecan use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer
Detailed Description:
PRIMARY OBJECTIVES
I Compare the survival and response of patients with stage IVB recurrent or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin
II Compare the toxic effects of these regimens in these patients III Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 4 treatment arms
ARM I Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2
ARM II Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1
ARM III Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II
ARM IV Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II
In all arms treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before courses 2 and 5 and at 9 months after study entry
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I Compare the survival and response of patients with stage IVB recurrent or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin
II Compare the toxic effects of these regimens in these patients III Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 4 treatment arms
ARM I Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2
ARM II Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1
ARM III Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II
ARM IV Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II
In all arms treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before courses 2 and 5 and at 9 months after study entry
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02540 | REGISTRY | None | None |
| CDR0000306463 | None | None | None |
| GOG-0204 | OTHER | None | None |
| GOG-0204 | OTHER | None | None |