NCT00002662已完成3 期
PHASE III COMPARISON OF TAXOTERE (DOCETAXEL) AND TAXOL (PACLITAXEL) IN PATIENTS WITH ADVANCED BREAST CANCER
Aventis Pharmaceuticals64 个研究点 分布在 1 个国家开始时间: 1994年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 64
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 whether paclitaxel is more effective than docetaxel for breast cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer.
详细描述
OBJECTIVES:
- Compare the response rate in women with metastatic or locally advanced, inoperable adenocarcinoma of the breast treated with docetaxel vs paclitaxel.
- Compare the toxicity of these regimens in these patients.
- Compare the time to disease progression, duration of response, quality of life, and survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and after courses 4 and 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
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 proven metastatic or locally advanced, inoperable adenocarcinoma of the breast
- •Clinically evident metastases (e.g., clearly malignant lesions on chest x-ray or CT or abdominal CT do not require histologic confirmation)
- •Hot spots on bone scan not shown to be malignant on plain x-rays are not adequate evidence of malignant disease in the absence of other lesions
- •Must meet 1 of the following conditions:
- •Disease progression after 1 prior chemotherapy regimen for locally advanced or metastatic disease (which may or may not have followed a separate adjuvant regimen using chemotherapy or hormonal therapy)
- •Locally advanced or metastatic disease during or after 1 adjuvant or neoadjuvant chemotherapy regimen
- •One of the above chemotherapy regimens must have contained an anthracycline (e.g., doxorubicin, but not mitoxantrone)
- •Single drug substitution (e.g., methotrexate for doxorubicin) during prior combination chemotherapy allowed
- •Bidimensionally measurable
- •No clinical or radiographic evidence of brain or leptomeningeal disease
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 60-100% OR
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 2,000/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin normal
- •SGOT no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •No uncontrolled hypercalcemia
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •No history of arrhythmia requiring treatment
- •No heart block
- •No clinical evidence of congestive heart failure
- •No unstable angina (e.g., new onset, crescendo, or rest angina)
- •Stable exertional angina allowed
- •No current symptomatic grade 2 or greater peripheral neuropathy
- •No history of hypersensitivity to products containing Cremophor EL (e.g., cyclosporine or teniposide) or Polysorbate 80 (e.g., IV etoposide)
- •No serious infection
- •No significant psychiatric disease that would preclude study
- •No other malignancy within the past 5 years except nonmelanomatous skin cancer or completely excised carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior bone marrow or stem cell transplantation
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy (2 weeks for oral cyclophosphamide or 6 weeks for nitrosoureas or mitomycin)
- •No prior high-dose chemotherapy given with ablative intent
- 另有 20 项未显示
排除标准
- 未提供
研究者
研究点 (64)
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