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A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma (NCT00003644)

National Cancer Institute (NCI)
Southwest Oncology Group
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer. PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.
  • Drug: carboplatin
    • Drug: paclitaxel
      Ages eligible for Study
      up to 120 Years
      Genders eligible for Study
      Female
      Accepts Healthy Volunteers
      No
      OBJECTIVES:

      - Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel.

      - Assess the frequency and severity of toxic effects of these regimens in these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

      - Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks.

      - Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo observation.

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

      PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.

      151 locations

      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      30 September, 1998
      Updated:
      16 March, 2016
      Participants:
      571
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