Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective and duration of response
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.
Amit M. Oza, MD
Princess Margaret Hospital, Canada
Canada: Health Canada
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Duluth Clinic||Duluth, Minnesota 55805|