NCT00005980已完成2 期
A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer
European Organisation for Research and Treatment of Cancer - EORTC28 个研究点 分布在 9 个国家目标入组 116 人开始时间: 2000年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 28
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 which regimen of liposomal doxorubicin is more effective for metastatic breast cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the response rate in women with metastatic breast cancer treated with two different dose schedules of doxorubicin HCL liposome.
- Assess the side effects of these treatment regimens in this patient population.
- Determine the duration of response in these patients treated with these regimens.
- Assess the concentration of doxorubicin in tumor tissue in patients with easily accessible metastases.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, performance status (0-1 vs 2), visceral disease (yes vs no), available lesions for biopsy (yes vs no), prior adjuvant anthracyclines (yes vs no), and prior chemotherapy for advanced disease (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive doxorubicin HCL liposome IV over 1 hour every 6 weeks.
- Arm II: Patients receive doxorubicin HCL liposome IV over 1 hour every 4 weeks. Treatment continues for at least 36 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
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 proven progressive or recurrent metastatic breast cancer
- •Bidimensionally measurable disease with at least one target lesion
- •If previously irradiated lesions:
- •No preirradiated only lesions
- •Clear progression prior to study
- •New lesions in a previously irradiated region allowed
- •Refusal of or medical contraindication to standard anthracycline containing regimen
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •Transaminases less than 2 times upper limit of normal
- •Creatinine normal
- •Cardiovascular:
- •Left ventricular ejection fraction normal by echocardiography or MUGA scan
- •No significant cardiac history including:
- •Clinically significant atrial or ventricular arrhythmias requiring treatment
- •Medically controlled congestive heart failure
- •Significant angina or clinically and/or electrocardiographically documented myocardial infarction within the past year
- •Clinically significant valvular disease
- •No other prior or concurrent malignancy within the past 5 years except contralateral breast cancer, or adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- •No psychological, familial, sociological, or geographical condition that would preclude study
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •Prior adjuvant chemotherapy allowed if total doxorubicin dose is no greater than 300 mg/m2, total epirubicin dose is no greater than 450 mg/m^2, and total mitoxantrone dose is no greater than 75 mg/m^2
- •No greater than one regimen of prior chemotherapy for metastatic disease
- •No prior anthracyclines for metastatic disease
- •No other concurrent cytotoxic therapy
- •Endocrine therapy:
- •No concurrent hormonal therapy
- •At least 4 weeks since prior progestins, estrogens, or androgens
- •Radiotherapy:
- •See Disease Characteristics
- •Concurrent palliative radiotherapy allowed if sole target lesion is outside irradiated field
- •Not specified
- •Concurrent bisphosphonates for metastatic bone disease and hypercalcemia secondary to malignancy allowed if bony lesions not only target lesion
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (28)
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