A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer

OBJECTIVES:

• Determine the response rate in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with erlotinib and carboplatin.
• Determine the duration of stable disease, time to progression, and response duration in patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.
• Correlate the level of epidermal growth factor receptor tumor expression with objective tumor response in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior platinum-containing therapy (platinum-sensitive, defined as 6 months or more since prior therapy with platinum agent [closed to accrual as of 2/13/2004], vs platinum-resistant, defined as less than 6 months since prior therapy with platinum agent).

Patients receive carboplatin IV over 30 minutes on day 1 and oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. After the completion of 6 courses of therapy, patients with responsive or stable disease may continue to receive erlotinib and carboplatin in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks and then every 3 months thereafter.