NCT00098982已完成1 期
Phase I Study of PS-341 (VELCADE) in Combination With 5FU/LV Plus Oxaliplatin in Patients With Advanced Colorectal Cancer
European Organisation for Research and Treatment of Cancer - EORTC6 个研究点 分布在 3 个国家目标入组 16 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Maximum tolerated dose and recommended dose of bortezomib as measured by CTC v3.0
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also help the chemotherapy drugs work better by making tumor cells more sensitive to the drugs. Giving bortezomib with fluorouracil, leucovorin, and oxaliplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given with fluorouracil, leucovorin, and oxaliplatin in treating patients with advanced or metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of bortezomib when administered with fluorouracil, leucovorin calcium, and oxaliplatin in patients with advanced or metastatic colorectal cancer.
- Determine the recommended phase II dose of bortezomib in patients treated with this regimen.
Secondary
- Determine response in patients with measurable disease treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed advanced or metastatic colorectal cancer
- •Amenable to first-line treatment with oxaliplatin, fluorouracil, and leucovorin calcium for advanced or metastatic disease
- •No symptomatic or radiologic evidence of brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- •AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- •Creatinine ≤ 1.7 mg/dL
- •Cardiovascular
- •No ischemic heart disease within the past 6 months
- •No clinically significant ECG changes
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No baseline neuropathy > grade 1
- •No other prior or concurrent malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
- •No unstable systemic disease
- •No active uncontrolled infection
- •No psychological, familial, sociological, or geographical condition that would preclude study participation
- •No hypersensitivity to bortezomib, boron, or mannitol
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior oxaliplatin
- •No prior chemotherapy for advanced or metastatic disease
- •At least 6 months since prior adjuvant chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •More than 14 days since prior major surgery
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose and recommended dose of bortezomib as measured by CTC v3.0
次要结局
- Safety as measured by CTC v3.0
- Response as measured by RECIST every 8 weeks
- Time to progression as measured by Kaplan Meier and RECIST every 8 weeks
研究者
研究点 (6)
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