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A Multicenter Randomized Trial, With Direct Individual Benefit, to Determine the Optimal Circadian Time of Vinorelbine Administration Combined With Chronomodulated Infusion of 5-Fluorouracil in Previously Treated Patients With Metastatic Breast Cancer (NCT00003730)

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. PURPOSE: Randomized clinical trial to study the effectiveness of vinorelbine plus fluorouracil in treating women who have metastatic breast cancer that has been previously treated with at least one regimen of chemotherapy.
  • Drug: fluorouracil
    • Drug: vinorelbine tartrate
      Ages eligible for Study
      Genders eligible for Study
      Accepts Healthy Volunteers

      - Determine the least toxic time of vinorelbine administration when combined with chronomodulated fluorouracil in women with previously treated metastatic breast cancer.

      - Determine the toxic effects and dose intensities of each drug in these women.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior chemotherapy (second line vs third line) and participating center. Patients are randomized to 1 of 8 vinorelbine dosing times (0000, 0300, 0600, 0900, 1200, 1500, 1800, or 2100).

      Patients receive vinorelbine IV over 20 minutes on days 1 and 6 and fluorouracil IV over 12 hours according to a chronomodulated delivery rate (2200 to 1000 with a maximum dose at 0400) on days 1-4. Treatment repeats every 3 weeks for at least 3 courses in the absence of unacceptable toxicity.

      Patients are followed for 30 days.

      PROJECTED ACCRUAL: A minimum of 80 patients (10 per dosing time) will be accrued for this study.

      17 locations

      30 November, 1998
      28 June, 2012
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