Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer

Phase 2

Completed

• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cavity Cancer

• Registration Number: NCT00010179
• Lead Sponsor: NCIC Clinical Trials Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-10-31
• Study First Submitted: 2001-02-02
• Primary Completion: 2002-10-22
• Study First Submitted QC: 2004-02-25
• Study First Posted: 2004-02-26
• Study Completion: 2008-09-22
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (14)

Tom Baker Cancer Center - Calgary; 🇨🇦 Calgary, Alberta, Canada

BCCC - Cancer Center for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

Nova Scotia Cancer Centre; 🇨🇦 Halifax, Nova Scotia, Canada

British Columbia Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

Royal Victoria Hospital - Montreal; 🇨🇦 Montreal, Quebec, Canada

City Hospital NHS Trust; 🇬🇧 Birmingham, England, United Kingdom

Christie Hospital N.H.S. Trust; 🇬🇧 Manchester, England, United Kingdom

Newcastle General Hospital; 🇬🇧 Newcastle Upon Tyne, England, United Kingdom

Weston Park Hospital; 🇬🇧 Sheffield, England, United Kingdom

Beatson Oncology Centre; 🇬🇧 Glasgow, Scotland, United Kingdom

Queen's University; 🇨🇦 Kingston, Ontario, Canada

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

Royal Marsden NHS Trust; 🇬🇧 London, England, United Kingdom

CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada