NCT00049660终止2 期
A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer
European Organisation for Research and Treatment of Cancer - EORTC24 个研究点 分布在 5 个国家目标入组 47 人开始时间: 2002年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 24
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. It is not yet known if capecitabine is more effective than vinorelbine in treating metastatic breast cancer.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy.
详细描述
OBJECTIVES: Phase II Study:
- Compare the response rate in women with previously treated metastatic breast cancer treated with capecitabine vs vinorelbine.
- Compare the duration of response in patients treated with these drugs.
Phase III Study:
- Compare overall and progression-free survival in patients treated with these drugs.
- Compare time to treatment failure in patients treated with these drugs.
- Compare overall safety of these drugs in these patients.
- Compare quality of life and clinical benefit response in patients treated with these drugs.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and taxane resistance (refractory vs resistant vs sensitive).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer
- •Metastatic disease
- •Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting
- •Taxane-resistant disease allowed regardless of duration of prior therapy NOTE: Resistant disease defined as progression during or within 12 weeks after taxane therapy for metastatic disease or a disease-free interval of less than 12 months after neoadjuvant or adjuvant therapy with a taxane
- •Taxane-sensitive disease allowed if at least 4 prior courses were received NOTE: Sensitive disease defined as progression occurring more than 12 weeks after taxane therapy for metastatic disease or more than 12 months after neoadjuvant or adjuvant therapy with a taxane
- •Prior treatment with anthracyclines for metastatic disease or as adjuvant treatment OR medical contraindication to treatment with anthracyclines
- •At least one unidimensionally measurable lesion (phase II study)
- •No CNS metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Karnofsky 70-100%
- •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 1.25 times upper limit of normal (ULN)
- •Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- •Creatinine clearance greater than 50 mL/min
- •Cardiovascular
- •No symptomatic ventricular arrhythmias
- •No clinically significant congestive heart failure
- •No clinical or ECG evidence of myocardial infarction within the past 12 months
- •No significant coronary artery disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No prior malignancy within the past 5 years except contralateral breast cancer, nonmelanoma skin cancer, and adequately treated carcinoma in situ of the cervix
- •No known or prior sensitivity to fluoropyrimidines, including fluorouracil
- •No pre-existing grade 2 or greater neurotoxicity
- •No known malabsorption or upper gastrointestinal abnormalities that would affect absorption of study drug
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent biologic therapy
- •Chemotherapy
- •See Disease Characteristics
- •No more than 2 prior chemotherapy lines for metastatic disease
- •No prior capecitabine, vinca alkaloids, or continuous fluorouracil
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Prior hormonal therapy allowed
- •No concurrent hormonal therapy
- •Radiotherapy
- •No concurrent radiotherapy
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (24)
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