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Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: October 8, 2008   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003730
  Purpose

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 Intervention
Breast Cancer
Drug: fluorouracil
Drug: vinorelbine ditartrate

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 80
Study Start Date: December 1998
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine no greater than 1.58 mg/dL

Cardiovascular:

  • No clinically significant cardiac insufficiency or ischemic disease

Pulmonary:

  • No bronchoconstriction other than pulmonary lymphangitis

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy
  • No concurrent prophylactic growth factor

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • Not specified

Other:

  • No other concurrent antitumor therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003730

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

Additional Information:
Publications:
Study ID Numbers: CDR0000066843, EORTC-05971
Study First Received: November 1, 1999
Last Updated: October 8, 2008
ClinicalTrials.gov Identifier: NCT00003730     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

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

ClinicalTrials.gov processed this record on November 27, 2009