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A Phase I/II Study to Determine the Maximum Tolerated Doses of Oral Topotecan, Carboplatin and Paclitaxel Administered Every 21 Days to Patients With Epithelial Ovarian Cancer Stages IIb, IIc, III and IV (NCT00003732)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II, stage III, or stage IV ovarian cancer.
  • Drug: carboplatin
    • Drug: paclitaxel
      • Drug: topotecan hydrochloride
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        Female
        Accepts Healthy Volunteers
        No
        OBJECTIVES:

        - Determine the maximum tolerated dose, dose-limiting toxicity, and quantitative and qualitative toxic effects of oral topotecan combined with intravenous carboplatin and paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial cancer. (phase I closed to accrual 12/21/00)

        - Evaluate the anti-tumor activity of this regimen in this patient population.

        OUTLINE: This is a multicenter, dose-escalation study of topotecan.

        Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 5. Courses repeat every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

        - Phase I: Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. (phase I closed to accrual 12/21/00)

        - Phase II: An additional 50 patients receive up to 6 courses of treatment as in phase I at the MTD.

        Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

        PROJECTED ACCRUAL: A total of 80 patients (30 in phase I and 50 in phase II) will be accrued for this study. (phase I closed to accrual 12/21/00)

        1 locations

        Denmark (1)
        • Rigshospitalet - Copenhagen University Hospital
          Copenhagen, Denmark, 2100
        Status:
        completed
        Type:
        Interventional
        Phase:
        Start:
        31 August, 1998
        Updated:
        08 August, 2013
        Participants:
        80
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