Ovarian Cancer Clinical Trial
Official title:
A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor
cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop
tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin
may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining erlotinib and carboplatin in
treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal 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.
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