Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial 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.
|Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer||Drug: lurtotecan liposome||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Randomized Phase II Study Of NX 211 Given By Two Different Intravenous Schedules In Advanced And/Or Recurrent Epithelial Ovarian Cancer|
|Study Start Date:||June 2000|
|Study Completion Date:||September 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010179
|Tom Baker Cancer Center - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Canada, British Columbia|
|BCCC - Cancer Center for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, Nova Scotia|
|Nova Scotia Cancer Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Kingston, Ontario, Canada, K7L 3N6|
|Royal Victoria Hospital - Montreal|
|Montreal, Quebec, Canada, H3A 1A1|
|Royal University Hospital|
|Saskatoon, Saskatchewan, Canada, S7N 0XO|
|City Hospital NHS Trust|
|Birmingham, England, United Kingdom, B18 7QH|
|Royal Marsden NHS Trust|
|London, England, United Kingdom, SW3 6JJ|
|Christie Hospital N.H.S. Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Newcastle General Hospital|
|Newcastle Upon Tyne, England, United Kingdom, NE4 6BE|
|Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Robert N. Grimshaw, MD||Nova Scotia Cancer Centre|