Ovarian Cancer Clinical Trial
Official title:
Randomized Phase II Study Of NX 211 Given By Two Different Intravenous Schedules In Advanced And/Or Recurrent Epithelial Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing of die.
PURPOSE: Randomized phase II trial to compare the effectiveness of two treatment regimens of
lurtotecan liposome in patients who have advanced or recurrent ovarian epithelial cancer,
primary fallopian tube cancer, or peritoneal cancer that has been previously treated with
chemotherapy.
OBJECTIVES: I. Compare the anti-tumor efficacy of two treatment schedules of lurtotecan
liposome, in terms of clinical/radiological response and CA125 tumor marker, in patients with
previously treated advanced or recurrent ovarian epithelial cancer. II. Compare the safety,
pharmacokinetics, and possible pharmacokinetic/pharmacodynamic relationships of these
treatment schedules in these patients. III. Compare the time to progression in patients
treated with these treatment schedules.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to time
from last prior chemotherapy (less than 6 months vs 6 months or more) and number of prior
chemotherapy regimens (1 vs 2). Patients are randomized to one of two treatment arms. Arm I:
Patients receive lurtotecan liposome IV over 30 minutes on days 1-3. Arm II: Patients receive
lurtotecan liposome IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the
absence of disease progression or unacceptable toxicity. Patients achieving complete response
(CR) receive 2 additional courses after documented CR. Patients achieving partial response
(PR) receive 4 additional courses after documented PR or until disease progression at
investigator's discretion. Patients with stable disease continue therapy for a maximum of 6
courses. Patients are followed at 4 weeks and then every 3 months until disease relapse or
progression.
PROJECTED ACCRUAL: A total of 40-74 patients (20-37 per treatment arm) will be accrued for
this study within 10 months.
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