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A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III & IV or Recurrent Endometrial Carcinoma (NCT00003691)

National Cancer Institute (NCI)
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 tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.
  • Biological: filgrastim
    • Drug: cisplatin
      • Drug: doxorubicin hydrochloride
        • Drug: paclitaxel
          Ages eligible for Study
          18 Years and older
          Genders eligible for Study
          Female
          Accepts Healthy Volunteers
          No
          OBJECTIVES:

          - Determine whether the addition of paclitaxel, using filgrastim (G-CSF) support, to standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of objective response, progression-free survival, or overall survival in patients with stage III, stage IV, or recurrent endometrial carcinoma.

          - Compare the toxicities of these two regimens in these patients.

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

          - Arm I: Patients receive doxorubicin IV over 15-30 minutes, followed immediately by cisplatin IV over 1 hour.

          - Arm II: Patients receive doxorubicin and cisplatin as in arm I on day 1. On day 2, patients receive paclitaxel IV over 3 hours. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for at least 10 days.

          Courses are repeated every 21 days. Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity.

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

          PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 21 months.

          73 locations

          Status:
          completed
          Type:
          Interventional
          Phase:
          Start:
          30 November, 1998
          Updated:
          07 July, 2013
          Participants:
          240
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