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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 34
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Not specified
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm ^3
- •Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- •AST/ALT no greater than 2.5 times ULN
- •Creatinine no greater than 1.58 mg/dL
- •Cardiovascular:
- •No clinically significant cardiac insufficiency or ischemic disease
- •No bronchoconstriction other than pulmonary lymphangitis
- •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
- •Not specified
- •No other concurrent antitumor therapy
排除标准
- 未提供