Ovarian Cancer Clinical Trial
Official title:
A Phase II Trial of ZD1839 (Iressa) (NSC# 715055) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor
cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who
have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
OBJECTIVES:
- Determine the antitumor cytostatic activity of gefitinib, in terms of 6-month
progression-free survival, in patients with persistent or recurrent ovarian epithelial
or primary peritoneal carcinoma.
- Determine the nature and degree of toxicity in patients treated with this drug.
- Determine the partial and complete response rates in patients treated with this drug.
- Determine the duration of progression-free and overall survival in patients treated
with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 1-2
years.
;
Primary Purpose: Treatment
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