NCT00026442Unknown2 期
A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer
Pharmatech Oncology20 个研究点 分布在 1 个国家开始时间: 2001年11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
- 试验地点
- 20
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: Randomized phase II trial to compare the effectiveness of two different doses of capecitabine in treating women who have advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
- Compare the objective response rate in women with advanced or metastatic breast cancer treated with two dose levels of capecitabine.
- Compare the duration of response, time to progression, time to treatment failure, survival, incidence of adverse events, and time to onset of the adverse experience in patients treated with this drug.
- Compare the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Karnofsky performance status (70-80% vs 90-100%) and presence of hepatic metastases (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive lower-dose oral capecitabine twice daily on days 1-14.
- Arm II: Patients receive higher-dose oral capecitabine twice daily on days 1-14.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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 and/or cytologically confirmed breast cancer
- •Advanced and/or metastatic disease
- •At least 1 measurable lesion
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •No CNS metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- •AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- •Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present OR 10 times ULN if bone metastases present)
- •No hepatitis
- •Creatinine no greater than 1.5 times ULN
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular:
- •No clinically significant cardiac disease
- •No congestive heart failure
- •No symptomatic coronary artery disease
- •No cardiac arrhythmias poorly controlled with medication
- •No myocardial infarction within the past 12 months even if adequately controlled with medication
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No severe pain inadequately controlled by analgesics
- •No prior severe and unexpected reaction to fluoropyrimidine therapy
- •No known hypersensitivity to fluorouracil
- •No impaired physical integrity of the upper gastrointestinal tract
- •No malabsorption syndrome
- •No inability to swallow tablets
- •No history of uncontrolled seizures, central nervous system disorder, or psychiatric disability that would preclude study participation
- •No serious uncontrolled infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 2 but no more than 3 prior chemotherapy regimens
- •At least 1 prior chemotherapy regimen containing paclitaxel and an anthracycline as adjuvant therapy or for advanced and/or metastatic disease
- •Endocrine therapy:
- 另有 8 项未显示
排除标准
- 未提供
研究者
研究点 (20)
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