Gemcitabine, Capecitabine, and Oxaliplatin as Second-Line Therapy in Treating Patients With Advanced Colorectal Cancer Previously Treated With Irinotecan
A Phase I/II Study to Determine the Safety and Efficacy of Second-Line Treatment With XELOX Plus Gemcitabine in Irinotecan Pre-Treated Advanced Colorectal Cancer Patients
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, capecitabine, and oxaliplatin, 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 I/II trial is studying the side effects and best dose of gemcitabine when given together with capecitabine and oxaliplatin as second-line therapy and to see how well it works in treating patients with advanced colorectal cancer previously treated with irinotecan.
研究概览
详细说明
OBJECTIVES:
Primary
- Define the dose-limiting toxicity and maximum tolerated dose of gemcitabine hydrochloride when administered with capecitabine and oxaliplatin as second-line therapy in patients with advanced colorectal cancer previously treated with irinotecan hydrochloride. (Phase I)
- Determine the recommended phase II dose of gemcitabine hydrochloride in these patients. (Phase I)
- Assess overall response rate in patients treated with this regimen. (Phase II)
Secondary
- Assess the progression-free survival of patients treated with this regimen. (Phase II)
- Assess the time to treatment failure, duration of response, and time to response in patients treated with this regimen. (Phase II)
- Assess the overall survival of patients treated with this regimen. (Phase II)
- Assess the safety of this regimen in these patients. (Phase II)
OUTLINE: This is a multicenter, phase I, dose-escalation study of gemcitabine hydrochloride, followed by a phase II, open-label study.
- Phase I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, oral capecitabine twice daily on days 1-14, and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days.
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the maximum tolerated dose (MTD) is determined.
- Phase II: Patients receive gemcitabine hydrochloride at the MTD determined in phase I and capecitabine and oxaliplatin as in phase I.
研究类型
注册 (预期的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Seoul、大韩民国、120-752
- 招聘中
- Yonsei Cancer Center at Yonsei University Medical Center
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接触:
- Joong B. Ahn, MD
- 电话号码:82-2-2228-8134
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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 advanced colorectal adenocarcinoma
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Must have received prior irinotecan hydrochloride with a progression-free interval of < 3 months
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 2 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
- Creatinine ≤ 1.5 times ULN
- No significant cardiac abnormalities by ECG
- No known hypersensitivity to the study drugs or any of their components
- No myocardial infarction within the past 12 months
- No uncontrolled congestive heart failure
- No cardiovascular disorder ≥ grade 3 despite treatment
- No other malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
- No significant disease, that in the opinion of the investigator, would preclude study treatment (e.g., active infections, interstitial lung disease, or peripheral neuropathy)
- No history of significant neurological or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder)
- No legal incapacity or limited legal capacity that would preclude study participation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- More than 30 days since prior participation in another clinical trial
- No concurrent warfarin, phenprocoumon, phenytoin, or sorivudine
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 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 |
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Overall response rate as assessed by RECIST criteria
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次要结果测量
结果测量 |
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治疗失败时间
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无进展生存期
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总生存期
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反应持续时间
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响应时间
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合作者和调查者
调查人员
- 首席研究员:Joong B. Ahn, MD、Yonsei University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
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
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
奥沙利铂的临床试验
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Hospices Civils de Lyon未知