A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer
A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer
研究概览
详细说明
Combination chemotherapy has advantages over monochemotherapy due to the higher response rates that can often be obtained; by using agents with non-overlapping toxicity profiles, these responses can be achieved with less toxicity than maximally tolerated doses of single agents. One significant advantage of capecitabine/weekly docetaxel combination chemotherapy is that both agents appear to have a toxicity profile appropriate for palliative therapy of advanced breast cancer. This trial will utilize the usual schedule of capecitabine used in the USA, which is two times per day oral dosing for 14 days but at a reduced dose in hopes of decreasing toxicities. Docetaxel will be given weekly at a dose of 35 mg/m2 X 2 with a one-week rest to coincide with the 14-day schedule of capecitabine.
The primary objective is to evaluate the overall response rate (complete and partial responses) according to the RECIST criteria of the combination of capecitabine and docetaxel with the selected schedule in patients with advanced and/or metastatic breast cancer. The secondary objectives are to evaluate tolerability, time to tumor progression, and time to treatment failure of the combination of capecitabine and docetaxel.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Florida
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Plantation、Florida、美国、33324
- Cancer Research Network, Inc.
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Female patients with histopathologically proven metastatic breast cancer.
- Patients 18-75 years old
- Performance status: Karnofsky > 70%
- Patients must have measurable disease. Patients with only blastic bone lesions are ineligible.
- Adequate bone marrow, liver, renal and cardiac functions defined as:
- Ability to understand the study and give informed consent.
- Patients may not have received more than one prior chemotherapy for metastatic breast cancer. 5-FU or Taxol given as part of an adjuvant regimen will not render the patient ineligible.
Exclusion Criteria:
- Patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for > 3 months.
- Patients who have received any anti-cancer investigational agent in the month prior to inclusion.
- Patients previously treated with docetaxel(Taxotere)or capecitabine (Xeloda).
- Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
- Patients with renal impairment (creatinine clearance below 30 ml/min calculated according to Cockcroft and Gault, see Appendix D), since capecitabine is contraindicated in patients with severe renal impairment.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination
大体时间:2 years
|
2 years
|
合作者和调查者
调查人员
- 首席研究员:Charles L Vogel, MD、Cancer Research Network, Inc
- 学习椅:Elizabeth Tan-Chiu, MD、Cancer Research Network, Inc.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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