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
N/A
N/A
Female
Breast Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Bruno Coudert, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Authority:
United States: Federal Government
Study ID:
EORTC-05971
NCT ID:
NCT00003730
Start Date:
December 1998
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
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