NCT00075413撤回2 期
A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast
适应症
相关药物
试验速览
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating women with locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety and activity of arsenic trioxide in women with locally advanced or metastatic breast cancer.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
Secondary
- Determine the response, in terms of objective tumor response and response duration, in patients treated with this drug.
- Determine the patterns of failure and survival in patients treated with this drug.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer, meeting 1 of the following criteria:
- •Locally advanced disease
- •Cannot be adequately treated by radiotherapy or surgery
- •Metastatic disease
- •Ineligible for OR received prior anthracycline- and/or taxane-based chemotherapy with subsequent disease progression
- •No uncontrolled Central Nervous System (CNS) metastases
- •Ineligible for treatment protocols of higher priority
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Eastern Cooperative Oncology Group (ECOG) 0-1 OR
- •Southwest Oncology Group (SWOG) 0-1 OR
- •Zubrod 0-1
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin no greater than 1.5 times normal
- •Serum Glutamic Oxalacetic Transaminase (SGOT)/Serum Glutamic Pyruvic Transaminase (SGPT) no greater than 3 times normal
- •Creatinine no greater than 2.0 mg/dL
- •Calcium no greater than 12 mg/dL
- •Cardiovascular
- •Cardiac ejection fraction greater than 50%
- •No myocardial infarction or ischemia within the past 6 months
- •No uncontrolled clinically significant dysrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Electrolytes normal
- •Magnesium normal
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No prior or ongoing grade 2-4 peripheral neuropathy
- •No comorbid condition that would render the patient at high risk from study treatment complications
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent cytokine therapy
- •Chemotherapy
- •See Disease Characteristics
- •No more than 3 prior chemotherapy regimens for breast cancer
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 2 weeks since prior radiotherapy
- 另有 10 项未显示
排除标准
- 未提供
研究者
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