NCT00290680已完成1 期
Phase I Trial of Bortezomib (VELCADE™) and Celecoxib in Patients With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Bortezomib and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with celecoxib may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib and celecoxib in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of bortezomib and celecoxib in patients with advanced solid tumors.
Secondary
- Determine the overall pattern of toxicities associated with this combination, including the emergence of any cumulative toxicities, during multiple courses of this regimen.
- Describe the response rate and duration of response or disease stability during therapy in the subset of patients with measurable disease.
- Assess changes in plasma/serum sphingosine-1-phosphate, ceramide, and other markers of the apoptotic pathway before and during therapy.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologic or cytologic diagnosis of a malignant neoplasm (solid tumor) arising from any primary site with the exception of bone marrow or lymphoid tissue
- •Recurrent or progressive disease after chemotherapy or radiotherapy
- •Chemotherapy or radiotherapy-naive disease allowed if patient is not a candidate for standard treatment either due to comorbidities or lack of willingness to undergo standard treatment
- •Measurable disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 30 mL/min
- •Bilirubin ≤ 2 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active concurrent invasive malignancy
- •No peripheral neuropathy ≥ grade 2 within the past 14 days
- •No hypersensitivity to bortezomib, boron, mannitol, any of the cyclooxygenase (COX-2) inhibitors, sulfa drugs, or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- •No active gastrointestinal (GI) ulcers OR history of GI bleeding resulting from prior therapy with NSAIDs
- •PRIOR CONCURRENT THERAPY:
- •At least 2 weeks since completion of prior radiotherapy
- •No prior bortezomib
- •No other concurrent investigational agents
- •No concurrent chemotherapy, radiotherapy, or anticancer surgery
- •No concurrent immune-enhancing therapy
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
次要结局
- Response and disease progression by RECIST criteria before each course
研究者
研究点 (1)
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