Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086892
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2004-07-08
Brief Title:
Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation of Cetuximab C225 NSC 714692 in Combination With Carboplatin NSC 241240 in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2014-02
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 Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die Combining cetuximab with carboplatin may kill more tumor cells
PURPOSE This phase II trial is studying how well giving cetuximab together with carboplatin works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal cancer
PURPOSE This phase II trial is studying how well giving cetuximab together with carboplatin works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity of cetuximab and carboplatin in patients with recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer
Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 1 hour over 2 hours on day 1 of course 1 only on days 1 8 and 15 Patients also receive carboplatin IV after cetuximab administration on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 20-65 patients will be accrued for this study
Determine the antitumor activity of cetuximab and carboplatin in patients with recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer
Determine the nature and degree of toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 1 hour over 2 hours on day 1 of course 1 only on days 1 8 and 15 Patients also receive carboplatin IV after cetuximab administration on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 20-65 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000371712 | None | None | None |
| BMS-CA225-019 | None | None | None |