Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works in treating patients with metastatic prostate cancer.
研究概览
详细说明
OBJECTIVES:
Primary
- Determine the response rate in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with capecitabine and docetaxel.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
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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Michigan
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Detroit、Michigan、美国、48201-1379
- Barbara Ann Karmanos Cancer institute
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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
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
- Metastatic disease
- Androgen-independent disease
Progressive disease, as documented by ≥ 1 of the following criteria:
Rising prostate-specific antigen (PSA) despite androgen deprivation therapy and anti-androgen withdrawal
- Demonstrates a rising PSA trend with 2 successive elevations ≥ 1 week apart
- Measurable disease progression
Nonmeasurable disease progression, defined as the following:
- PSA ≥ 5 ng/mL
- New areas of bone metastases on bone scan
Serum testosterone ≤ 0.5 ng/mL (castrate level)
- Concurrent luteinizing hormone-releasing hormone agonist therapy required for medically castrated patients
PATIENT CHARACTERISTICS:
Performance status
- Zubrod 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,500/ mm^3
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin normal
Transaminases meeting 1 of the following criteria:
- AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) normal
- AP ≤ 4 times ULN if AST and/or ALT normal
Renal
- Creatinine clearance ≥ 50 mL/min OR
- Creatinine ≤ 2 mg/dL
Cardiovascular
- No congestive heart failure
- No second- or third-degree heart block
- No myocardial infarction within the past 3 months
Other
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No other malignancy within the past 2 years except adequately treated skin cancer or other cancer in complete remission
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior chemotherapy for metastatic disease
Endocrine therapy
- See Disease Characteristics
- More than 4 weeks since prior flutamide
- More than 6 weeks since prior bicalutamide or nilutamide
Radiotherapy
- At least 4 weeks since prior radiotherapy
Other
- At least 28 days since prior investigational drugs for prostate cancer
- No other concurrent anti-cancer therapy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Docetaxel & Capecitabine
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
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Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
其他名称:
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Response rate by RECIST criteria after every 2 courses
大体时间:at cycle 2 and every other cycle thereafter
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at cycle 2 and every other cycle thereafter
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Toxicity at 30 days after last treatment
大体时间:Every week during treatment cycles
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Every week during treatment cycles
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Progression-free survival
大体时间:Every 2 cycles
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Every 2 cycles
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Time to treatment failure
大体时间:Every 2 cycles
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From date of registration to date of progressive disease, or date patient is taken off study for any other reason.
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Every 2 cycles
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Overall survival
大体时间:Every 2 cycles
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Every 2 cycles
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Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase)
大体时间:Every week during treatment cycles
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Every week during treatment cycles
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合作者和调查者
调查人员
- 学习椅:Ulka N. Vaishampayan, MD、Barbara Ann Karmanos Cancer institute
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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capecitabine的临床试验
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AstraZenecaSWOG Clinical Trials Partnerships; Daiichi Sankyo招聘中乳腺癌美国, 中国, 丹麦, 英国, 大韩民国, 加拿大, 德国, 意大利, 比利时, 西班牙, 日本, 法国, 台湾, 希腊, 巴西, 瑞典, 波多黎各
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AstraZenecaDaiichi Sankyo招聘中乳腺癌中国, 美国, 意大利, 西班牙, 英国, 大韩民国, 加拿大, 德国, 波兰, 比利时, 日本, 越南, 保加利亚, 法国, 巴西, 印度, 马来西亚, 台湾, 泰国, 匈牙利, 澳大利亚, 奥地利, 火鸡, 香港, 瑞士, 新加坡