ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer
- Registration Number
- NCT00003892
- 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 or die.
PURPOSE: Phase II trial to study the effectiveness of ISIS 5132 in treating patients who have metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy.
- Detailed Description
OBJECTIVES: I. Determine the efficacy of ISIS 5132 by evaluating objective response and duration of response in patients with recurrent ovarian epithelial cancer. II. Determine the tolerability and quantitative toxicity of ISIS 5132 in this patient population.
OUTLINE: This is a multicenter study. Patients receive ISIS 5132 IV continuously for 21 days. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients with documented complete response receive an additional 2 courses. Patients with documented partial response receive an additional 4 courses. Patients are followed at 4 weeks, then every 3 months until disease relapse or progression.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-15 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ISIS 5132 ISIS 5132 ISIS 5132 x 21 days IV infusion
- Primary Outcome Measures
Name Time Method Objective and duration of response 9 years To determine the efficacy of ISIS 5132 in patients with recurrent epithelial ovarian cancer, with evaluation of objective responses and duration of responses in patients receiving this compound in a phase II trial.
- Secondary Outcome Measures
Name Time Method Toxicity 9 years To determine the tolerability and quantitative toxicity of ISIS 5132 when given to patients with recurrent ovarian cancer
Trial Locations
- Locations (66)
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
🇨🇦Quebec City, Quebec, Canada
Peel Memorial Hospital
🇨🇦Brampton, Ontario, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Trillium Health Centre
🇨🇦Mississauga, Ontario, Canada
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
York County Hospital
🇨🇦Newmarket, Ontario, Canada
Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
St. Michael's Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Duluth Clinic
🇺🇸Duluth, Minnesota, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Royal Victoria Hospital, Barrie
🇨🇦Barrie, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
North York General Hospital, Ontario
🇨🇦North York, Ontario, Canada
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Lethbridge Cancer Clinic
🇨🇦Lethbridge, Alberta, Canada
St. Paul's Hospital - Vancouver
🇨🇦Vancouver, British Columbia, Canada
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
Burnaby Hospital Regional Cancer Centre
🇨🇦Burnaby, British Columbia, Canada
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Penticton Regional Hospital
🇨🇦Penticton, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Prostate Centre at Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Doctor Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Queen Elizabeth II Health Science Center
🇨🇦Halifax, Nova Scotia, Canada
Centre Hospitalier Regional de Lanaudiere
🇨🇦Joliette, Quebec, Canada
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
Hotel Dieu de Montreal
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de l'Universite' de Montreal - Pavillon Saint-Luc, Montreal
🇨🇦Montreal, Quebec, Canada
Centre Universitaire de Sante de l'Estrie
🇨🇦Fleurimont, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Queen Elizabeth Hospital, PEI
🇨🇦Charlottetown, Prince Edward Island, Canada
McGill University Department of Oncology
🇨🇦Montreal, Quebec, Canada
St. Mary's Hospital Center
🇨🇦Montreal, Quebec, Canada
Royal Victoria Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
Queen Elizabeth Hospital, Montreal
🇨🇦Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Hopital du Saint-Sacrament, Quebec
🇨🇦Quebec City, Quebec, Canada
Hopital du Haut-Richelieu
🇨🇦Saint Jean-Sur-Richelieu, Quebec, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Royal South Hants Hospital
🇬🇧Southampton, England, United Kingdom
Ottawa Regional Cancer Center - General Division
🇨🇦Ottawa, Ontario, Canada
Ottawa Regional Cancer Centre - Civic Campus
🇨🇦Ottawa, Ontario, Canada
Algoma District Medical Group
🇨🇦Sault Sainte Marie, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
🇨🇦Toronto, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
Saint Joseph's Health Centre - Toronto
🇨🇦Toronto, Ontario, Canada
Humber River Regional Hospital
🇨🇦Weston, Ontario, Canada
Peterborough Oncology Clinic
🇨🇦Peterborough, Ontario, Canada
Scarborough Hospital - General Site
🇨🇦Scarborough, Ontario, Canada
Hotel Dieu Hospital - St. Catharines
🇨🇦St. Catharines, Ontario, Canada