Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043082
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2002-08-05
Brief Title:
S0200 Carboplatin With or Without Doxil in Patients With Recurrent Ovarian Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase III Study of Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients With Recurrent Epithelial Ovarian and Peritoneal Carcinoma After Failure of Initial Platinum-Based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2015-10
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 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 if carboplatin is more effective with or without liposomal doxorubicin in treating recurrent ovarian epithelial or primary peritoneal cancer
PURPOSE Randomized phase III trial to determine the effectiveness of carboplatin with or without liposomal doxorubicin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer
PURPOSE Randomized phase III trial to determine the effectiveness of carboplatin with or without liposomal doxorubicin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Compare overall survival of patients with platinum-sensitive recurrent ovarian epithelial or primary peritoneal cancer treated with carboplatin with or without pegylated doxorubicin HCl liposome
Compare progression-free survival confirmed complete response rates and time to treatment failure in patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease measurability elevated CA 125 only vs nonmeasurable disease only with or without elevated CA 125 vs measurable disease number of disease sites 2 or fewer vs 3 or more and serous tumor histology yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive carboplatin IV over 15 minutes and pegylated doxorubicin HCl liposome IV over 1 hour on day 1
Arm II Patients receive carboplatin IV as in arm I Treatment in both arms repeats every 4 weeks for a total of 15 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks every 6 months for 3 years and then annually for 7 years
PROJECTED ACCRUAL A total of 900 patients will be accrued for this study within 4 years
Compare overall survival of patients with platinum-sensitive recurrent ovarian epithelial or primary peritoneal cancer treated with carboplatin with or without pegylated doxorubicin HCl liposome
Compare progression-free survival confirmed complete response rates and time to treatment failure in patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease measurability elevated CA 125 only vs nonmeasurable disease only with or without elevated CA 125 vs measurable disease number of disease sites 2 or fewer vs 3 or more and serous tumor histology yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive carboplatin IV over 15 minutes and pegylated doxorubicin HCl liposome IV over 1 hour on day 1
Arm II Patients receive carboplatin IV as in arm I Treatment in both arms repeats every 4 weeks for a total of 15 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks every 6 months for 3 years and then annually for 7 years
PROJECTED ACCRUAL A total of 900 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| S0200 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |