Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003730
• Other study ID #: EORTC-05971
• Secondary ID: EORTC-05971
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: June 29, 2012
• Start date: December 1998

Study information

• Verified date: June 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• fluorouracil

• vinorelbine tartrate

Locations

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

Sponsors (1)

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

Countries where clinical trial is conducted

Belgium,  France,  Greece,  Italy, 

References & Publications (2)

Coudert B, Focan C, Genet D, et al.: Optimal circadian time of vinorelbine (V) combined with chronomodulated 5-FU in pretreated metastatic breast cancer patients. EORTC 05971 randomized multicenter study. [Abstract] J Clin Oncol 24 (Suppl 18): A-2066, 200

Coudert B, Focan C, Genet D, Giacchetti S, Cvickovic F, Zambelli A, Fillet G, Chollet P, Amoroso D, Van Der Auwera J, Lentz MA, Marreaud S, Baron B, Gorlia T, Biville F, Lévi F. A randomized multicenter study of optimal circadian time of vinorelbine combi — View Citation