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
- 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
Patients are followed for 30 days.
PROJECTED ACCRUAL: A minimum of 80 patients (10 per dosing time) will be accrued for this
Allocation: Randomized, Primary Purpose: Treatment
Bruno Coudert, MD
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
United States: Federal Government