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Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer (NCT00003892)

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.
  • Drug: ISIS 5132
    4mg/kg/day IV for 21 days every 4 weeks.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Female
    Accepts Healthy Volunteers
    No
    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.

    66 locations

    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 January, 1999
    Updated:
    19 September, 2012
    Participants:
    22
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