Ovarian Cancer Clinical Trial
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
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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