Randomized Phase II Study Of NX 211 Given By Two Different Intravenous Schedules In Advanced And/Or Recurrent Epithelial Ovarian Cancer
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.
Interventional
Primary Purpose: Treatment
Robert N. Grimshaw, MD
Study Chair
Nova Scotia Cancer Centre
United States: Federal Government
I138
NCT00010179
June 2000
September 2008
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