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)
Duluth Clinic
🇺🇸Duluth, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Lethbridge Cancer Clinic
🇨🇦Lethbridge, Alberta, Canada
Burnaby Hospital Regional Cancer Centre
🇨🇦Burnaby, 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
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital - Vancouver
🇨🇦Vancouver, British Columbia, Canada
Scroll for more (56 remaining)Duluth Clinic🇺🇸Duluth, Minnesota, United States