Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT00086892|
Recruitment Status : Completed
First Posted : July 12, 2004
Last Update Posted : February 14, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Primary Peritoneal Cavity Cancer||Biological: cetuximab Drug: carboplatin||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2004|
|Primary Completion Date :||April 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086892
Show 76 Study Locations
|Study Chair:||Angeles A. Secord, MD||Duke Cancer Institute|
|OverallOfficial:||Deborah K. Armstrong, MD||Sidney Kimmel Comprehensive Cancer Center|
|OverallOfficial:||Nita Maihle, PhD||Yale University|