NCT00003730

Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil
DRUG	vinorelbine tartrate

Timeline

• Start date: 1998-12-01
• Primary completion: 2004-11-01
• First posted: 2003-01-27
• Last updated: 2012-07-02

Locations

17 sites across 4 countries: Belgium, France, Greece, Italy