NCT00026078Unknown2 期
Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer
Grupo Oncologico Cooperativo del Sur16 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2001年3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
- 入组人数
- 42
- 试验地点
- 16
- 主要终点
- Response rate
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: Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating women who have metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of docetaxel and ifosfamide as first-line chemotherapy in women with metastatic breast cancer.
- Determine the response rate and duration of response of patients treated with this regimen.
- Determine the time to treatment failure and survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1 and ifosfamide IV over 1 hour (beginning 1 hour after docetaxel infusion) on days 1-3. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every month during study, and then every 3 months after completion of study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 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 confirmed metastatic breast cancer
- •Bidimensionally measurable lesions
- •The following are not considered measurable:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Inflammatory breast disease
- •Lymphangitis cutis/pulmonis
- •Disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation
- •No CNS metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status:
- •Not specified
- •Performance status:
- •ECOG 0-2 OR
- •Zubrod 0-2
- •Life expectancy:
- •More than 12 weeks
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 11 g/dL
- •Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- •SGOT no greater than 1.25 times ULN
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No history of congestive heart failure
- •No myocardial infarction within the past 6 months
- •No active ischemic heart disease
- •No uncontrolled hypertension
- •Not pregnant
- •No other prior or concurrent malignancy except properly treated basal cell skin cancer or carcinoma in situ of the cervix
- •No other medical or psychiatric diseases that would preclude study
- •No geographical situation that would preclude study
- •No history of alcohol abuse
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior adjuvant chemotherapy including ifosfamide or docetaxel
- •No prior systemic chemotherapy for metastatic breast cancer
- •Endocrine therapy:
- •See Disease Characteristics
- •No concurrent corticoids, gestagens, or androgens unless strictly indicated
- •Radiotherapy:
- •Not specified
- •Not specified
- 另有 1 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate
次要结局
- Time to treatment failure
- Duration of response
- Survival
- Toxicity as assessed by CTC version 2.0
- Quality of life as assessed by Schipper's Functional Living Index - Cancer
研究者
研究点 (16)
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