ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer|
- Objective and duration of response [ Time Frame: 9 years ] [ Designated as safety issue: No ]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.
- Toxicity [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]To determine the tolerability and quantitative toxicity of ISIS 5132 when given to patients with recurrent ovarian cancer
|Study Start Date:||February 1999|
|Study Completion Date:||September 2008|
|Primary Completion Date:||October 2000 (Final data collection date for primary outcome measure)|
Experimental: ISIS 5132
ISIS 5132 x 21 days IV infusion
Drug: ISIS 5132
4mg/kg/day IV for 21 days every 4 weeks.
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.
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|Study Chair:||Amit M. Oza, MD||Princess Margaret Hospital, Canada|