Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer

Not Applicable

Completed

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Locations (17): VZW Monica Campus Eeuwfeestkliniek
🇧🇪
Antwerpen, Belgium
University Hospital of Heraklion
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Iraklion (Heraklion), Crete, Greece
Istituto per la Ricerca e Cura del Cancro
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Candiolo (Turin), Italy
Ospedale San Carlo Borromeo
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Milano (Milan), Italy
Azienda Ospedale S. Luigi - Universita Di Turin
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Orbassano, (Torino), Italy
C.H.C - Asbl
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Liege, Belgium
Centre Jean Perrin
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Clermont-Ferrand, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
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Dijon, France
CHU Liege - Domaine Universitaire du Sart Tilman
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Liege, Belgium
Centre Rene Huguenin
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Saint Cloud, France
Hopital Perpetuel Secours
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Levallois-Perret, France
Hopital Saint-Louis
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Paris, France
Centre Hospital Regional Universitaire de Limoges
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Limoges, France
Hopital Bellevue
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Saint Etienne, France
Istituti Fisioterapici Ospitalieri - Roma
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Rome, Italy
Hopital Paul Brousse
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Villejuif, France
Fondazione Salvatore Maugeri
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Pavia, Italy