NCT00006120Unknown2 期
Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer
GERCOR - Multidisciplinary Oncology Cooperative Group69 个研究点 分布在 2 个国家开始时间: 2000年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 69
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.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
- Compare the response rate, progression free survival, and overall survival in women with unresectable locally advanced or metastatic breast cancer treated with two different schedules of docetaxel or paclitaxel.
- Compare the toxicities and pharmacoeconomics of these four regimens in these patients.
- Compare the quality of life of patients treated with these four regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, ECOG performance status, hormone receptor status (positive vs negative), metastasis to liver (yes vs no), and presence of disease progression following anthracyclines (yes vs no).
Patients are randomized to one of four treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1.
- Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
- Arm III: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36.
- Arm IV: Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven unresectable locally advanced or metastatic breast cancer
- •Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines
- •At least one bidimensionally measurable lesion
- •No brain metastasis
- •No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole site of metastatic disease
- •Hormone receptor status:
- •Known hormone receptor status
- •PATIENT CHARACTERISTICS:
- •Menopausal status:
- •Not specified
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •AST and ALT no greater than 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Bilirubin normal
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No uncontrolled angina or arrhythmia
- •No myocardial infarction within the past 6 months
- •No New York Heart Association class III or IV heart disease
- •No sensitive neuropathy worse than grade 2
- •No other significant, uncontrolled medical or psychiatric condition
- •No serious active infection
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior specific antitumoral immunotherapy
- •Chemotherapy:
- •See Disease Characteristics
- •No prior taxanes
- •At least 4 weeks since other prior specific antitumoral chemotherapy
- •Endocrine therapy:
- •At least 4 weeks since prior specific antitumoral hormonal therapy
- •Radiotherapy:
- •At least 4 weeks since prior specific antitumoral radiotherapy
- •Not specified
- •No other concurrent experimental medication
排除标准
- 未提供
研究者
研究点 (69)
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