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.
PROJECTED ACCRUAL: A total of 23-60 patients (8-30 for platinum-sensitive stratum [closed to
accrual as of 2/13/2004] and 15-30 for platinum-resistant stratum) will be accrued for this
study within 15-23 months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Hal W. Hirte, MD, FRCP(C)
Study Chair
Margaret and Charles Juravinski Cancer Centre
United States: Federal Government
I149
NCT00030446
January 2002
December 2009
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