NCT00006121终止2 期
Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy
European Organisation for Research and Treatment of Cancer - EORTC10 个研究点 分布在 7 个国家目标入组 18 人开始时间: 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
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 10
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 oxaliplatin in treating women who have advanced or metastatic breast cancer that has not responded to previous chemotherapy.
详细描述
OBJECTIVES:
- Determine the therapeutic activity of oxaliplatin in patients with advanced or metastatic breast cancer following failure of anthracycline/taxane based chemotherapy.
- Determine objective response, duration of response, and time to progression in these patients when treated with this regimen.
- Determine the acute side effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks until disease progression and then every 3 months for survival.
研究设计
- 研究类型
- Interventional
- 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 advanced or metastatic breast cancer
- •Bidimensionally measurable disease
- •At least one lesion at least 2 cm in one dimension by CT scan or MRI
- •Must have failed prior anthracycline/taxane based chemotherapy as defined by one of the following:
- •Stage IV disease treated with anthracycline/taxane combination as first line therapy for advanced or metastatic disease
- •Stage IV disease treated with first line anthracycline therapy and second line taxane therapy for advanced or metastatic disease
- •Any adjuvant treatment other than anthracycline based therapy followed by anthracycline/taxane combination as first line therapy for advanced or metastatic disease
- •Any adjuvant therapy other than anthracycline based therapy followed by first line anthracycline based therapy and second line taxane based therapy for advanced or metastatic disease
- •Adjuvant anthracycline based therapy followed by relapse after 6 months treated with anthracycline/taxane combination as first line therapy or first line anthracycline based therapy and second line taxane based therapy for advanced or metastatic disease
- •Adjuvant anthracycline based therapy followed by relapse within 6 months treated with first line taxane based therapy for advanced or metastatic disease
- •Disease progression within 6 months of last taxane based chemotherapy
- •No brain metastases
- •Hormonal receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Absolute neutrophil count greater than 2,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN in case of liver metastases)
- •Creatinine less than 1.25 times ULN
- •Cardiovascular:
- •LVEF at least 50% if prior total dose of doxorubicin 550 mg/m2 or greater, epirubicin 900 mg/m2 or greater, or pirarubicin 700 mg/m2 or greater
- •No prior or active congestive heart failure, myocardial infarction, or angina
- •No uncontrolled hypertension or arrhythmia
- •No unstable systemic disease
- •No active infection
- •No grade 2 or greater peripheral neuropathy
- •No psychological, familial, sociological, or geographical condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior high dose chemotherapy with hematopoietic rescue
- •No concurrent immunotherapy
- •No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) for prevention of neutropenia
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy
- •At least 1 prior taxane based chemotherapy for advanced or metastatic disease
- •No prior high dose chemotherapy with hematopoietic rescue
- •No prior platinum based chemotherapy
- •No prior taxane chemotherapy other than docetaxel or paclitaxel
- •No prior adjuvant or neoadjuvant therapy with taxane/anthracycline based combination chemotherapy
- •Endocrine therapy:
- 另有 10 项未显示
排除标准
- 未提供
研究者
研究点 (10)
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