Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	Not specified	Other	EORTC-05971 NCT00003730

Objectives

1. Determine the least toxic time of vinorelbine administration when combined with chronomodulated fluorouracil in women with previously treated metastatic breast cancer.
2. Determine the toxic effects and dose intensities of each drug in these women.

Entry 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

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

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/mm³
• 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

Expected Enrollment

A minimum of 80 patients (10 per dosing time) will be accrued for this study.

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.

Coudert B, Focan C, Genet D, et al.: 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 25 (5): 680-96, 2008.[PUBMED Abstract]

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, 2006.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Bruno Coudert, MD, Study coordinator		Ph: 33-3-8073-7528 Email: bcoudert@dijon.fnclcc.fr

Registry Information
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
Trial Start Date		1998-12-11
Registered in ClinicalTrials.gov		NCT00003730
Date Submitted to PDQ		1998-12-29
Information Last Verified		2004-12-02

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