A Phase II, Open, Randomized Multicenter Trial to Assess the Efficacy and Tolerability of Intravenous ZD9331 Given as Monotherapy (at Two Doses) or in Combination With Topotecan, in Patients With Ovarian Cancer Refractory or Recurrent After Failing Platinum and Paclitaxel in Combination
OBJECTIVES: I. Compare the efficacy of ZD9331 with or without topotecan in patients with
refractory or recurrent ovarian epithelial, primary peritoneal, or fallopian tube cancer.
II. Compare the tolerability of these regimens in these patients. III. Compare the objective
tumor response rate, progression-free survival, and disease control in patients treated with
these regimens. IV. Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 3 treatment arms. Arm I: Patients receive ZD9331 IV over 30 minutes on days 1 and 8. Arm
II: Patients receive a higher dose of ZD9331 IV over 30 minutes on days 1 and 8. Arm III:
Patients receive ZD9331 as in arm I and topotecan IV over 30 minutes on days 1-5. All arms:
Treatment repeats every 21 days in the absence of disease progression or unacceptable
toxicity. Quality of life is assessed at baseline, on the first day of each course, and then
at study withdrawal. Patients are followed at day 30, every 9 weeks until disease
progression, and then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 130 patients will be accrued for this study within 5
Primary Purpose: Treatment
Bernadette Matthews, RN, MSN, CCRA
United States: Federal Government
|AstraZeneca Pharmaceuticals LP||Wilmington, Delaware 19850-5437|