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A Phase II/III Trial of Chemotherapy Alone Versus Chemotherapy Plus SCH 58500 in Newly Diagnosed Stage III Ovarian and Primary Peritoneal Cancer Patients With Greater Than or Equal to 0.5 cm and Less Than or Equal to 2 cm Residual Disease Following Surgery (NCT00003880)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with gene therapy using SCH-58500 may kill more tumor cells. PURPOSE: Randomized phase II/III trial to determine the effectiveness of paclitaxel plus carboplatin with or without SCH-58500 in treating patients who have newly diagnosed stage III ovarian or stage III primary peritoneal cancer with residual disease following surgery to remove the tumor.
  • Biological: recombinant adenovirus-p53 SCH-58500
    • Drug: carboplatin
      • Drug: paclitaxel
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        Accepts Healthy Volunteers
        OBJECTIVES: I. Assess the effect of paclitaxel and carboplatin with or without SCH 58500 on progression free survival, overall survival, safety, response, and CA-125 levels in patients with newly diagnosed stage III ovarian epithelial or primary peritoneal cancer.

        OUTLINE: This is a randomized, open label, multicenter study. Patients receive treatment of IV paclitaxel and IV carboplatin. Patients are randomized to one of two treatment groups: Arm I: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin, on day 1. Courses are repeated every 21 days. Arm II: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin, on day 1. Patients receive intraperitoneal SCH 58500 on days 1-5. Courses are repeated every 21 days. Patients are followed every 6 weeks for 36 months, then every 3 months for 2 years, and then every 6 months until disease progression.

        PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this study.
        Ⅱ, Ⅲ
        31 January, 1999
        14 April, 2015
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