Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003730
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: fluorouracil Drug: vinorelbine tartrate Not Applicable

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Primary Purpose: Treatment
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
Study Start Date : December 1998
Actual Primary Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic breast cancer
  • At least 1 line of prior chemotherapy for metastatic disease (adjuvant or neoadjuvant chemotherapy is considered first line if completed less than one year prior to palliative chemotherapy)
  • No cerebral metastases
  • Hormonal receptor status:

    • Not specified



  • Not specified


  • Female

Menopausal status:

  • Not specified

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm ^3


  • Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN


  • Creatinine no greater than 1.58 mg/dL


  • No clinically significant cardiac insufficiency or ischemic disease


  • No bronchoconstriction other than pulmonary lymphangitis


  • No serious chronic disease
  • No bowel obstruction
  • Not pregnant or nursing


Biologic therapy:

  • No concurrent immunotherapy
  • No concurrent prophylactic growth factor


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No prior high-dose chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy
  • No concurrent steroid therapy except in an emergency


  • At least 4 weeks since prior radiotherapy (for primary tumor or axillary or mammary chain treatment only)
  • No concurrent radiotherapy


  • Not specified


  • No other concurrent antitumor therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003730

VZW Monica Campus Eeuwfeestkliniek
Antwerpen, Belgium, 2010
C.H.C - Asbl
Liege, Belgium, B 4000
CHU Liege - Domaine Universitaire du Sart Tilman
Liege, Belgium, B-4000
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
Hopital Perpetuel Secours
Levallois-Perret, France, 92300
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Hopital Saint-Louis
Paris, France, 75475
Centre Rene Huguenin
Saint Cloud, France, 92211
Hopital Bellevue
Saint Etienne, France, 42055
Hopital Paul Brousse
Villejuif, France, 94804
University Hospital of Heraklion
Iraklion (Heraklion), Crete, Greece, 71110
Istituto per la Ricerca e Cura del Cancro
Candiolo (Turin), Italy, 10180
Ospedale San Carlo Borromeo
Milano (Milan), Italy, 20153
Azienda Ospedale S. Luigi - Universita Di Turin
Orbassano, (Torino), Italy, 10043
Fondazione Salvatore Maugeri
Pavia, Italy, I-27100
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy, 00161
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Bruno Coudert, MD Centre Georges Francois Leclerc

Publications of Results:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00003730     History of Changes
Other Study ID Numbers: EORTC-05971
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators