Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: fluorouracil
* Drug: vinorelbine tartrate


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluorouracil|nan|
|Drug: vinorelbine tartrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer