Breast Cancer Clinical Trial
Official title:
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
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.
OBJECTIVES:
- 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.
;
Allocation: Randomized, Primary Purpose: Treatment
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