Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003120
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
1999-11-01
Brief Title:
S9701 Paclitaxel in Treating Patients With Advanced Ovarian Fallopian Tube or Primary Peritoneal Cancer in Remission
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase III Randomized Trial of 12 Months vs 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response CR Following PlatinumPaclitaxel-Based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2014-10
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 It is not yet known whether giving paclitaxel for a shorter period of time is as effective as a standard course of treatment for advanced ovarian cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel given for 3 months with that of paclitaxel given for 12 months in treating patients who have stage III or stage IV ovarian fallopian tube or primary peritoneal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel given for 3 months with that of paclitaxel given for 12 months in treating patients who have stage III or stage IV ovarian fallopian tube or primary peritoneal cancer
Detailed Description:
OBJECTIVES I Compare the effect of continuing paclitaxel for 12 months versus 3 months on progression free survival and overall survival in women with advanced ovarian fallopian tube or peritoneal cancer who attained complete remission on initial platinum carboplatin or cisplatin and paclitaxel based chemotherapy II Assess the toxic effects associated with prolonged paclitaxel administration in these patients
OUTLINE This is a randomized study Patients are stratified by stage optimal stage III vs suboptimal stage III vs stage IV prior treatments with paclitaxel over at least 24 hours vs over less than 24 hours and age 65 and under vs over 65 Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours on day 1 Treatment continues every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Arm II Patients receive paclitaxel IV over 3 hours on day 1 Treatment continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until disease progression or 1 year from registration then every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 450 patients 225 per arm will be accrued for this study within 5 years
OUTLINE This is a randomized study Patients are stratified by stage optimal stage III vs suboptimal stage III vs stage IV prior treatments with paclitaxel over at least 24 hours vs over less than 24 hours and age 65 and under vs over 65 Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours on day 1 Treatment continues every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Arm II Patients receive paclitaxel IV over 3 hours on day 1 Treatment continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until disease progression or 1 year from registration then every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 450 patients 225 per arm will be accrued for this study within 5 years
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 |
|---|---|---|---|
| U10CA032102 | NIH | GOG | httpsreporternihgovquickSearchU10CA032102 |
| SWOG-S9701 | OTHER | None | None |
| GOG-178 | OTHER | None | None |