Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer

NCT ID: NCT00003730

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

fluorouracil

Intervention Type: DRUG

vinorelbine tartrate

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Coudert, MD

Role: STUDY_CHAIR

Centre Georges Francois Leclerc

Locations

VZW Monica Campus Eeuwfeestkliniek

Antwerp, , Belgium

C.H.C - Asbl

Liège, , Belgium

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, , Belgium

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, , France

University Hospital of Heraklion

Iraklion (Heraklion), Crete, Greece

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, , Italy

Countries

Belgium; France; Greece; Italy

References

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, Levi F. A randomized multicenter study of optimal circadian time of vinorelbine combined with chronomodulated 5-fluorouracil in pretreated metastatic breast cancer patients: EORTC trial 05971. Chronobiol Int. 2008 Sep;25(5):680-96. doi: 10.1080/07420520802384036.

Reference Type: RESULT

PMID: 18780198 (View on PubMed)

Other Identifiers

EORTC-05971

Identifier Type: -

Identifier Source: secondary_id

EORTC-05971

Identifier Type: -

Identifier Source: org_study_id