NCT00072553Unknown2 期
A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study
GERCOR - Multidisciplinary Oncology Cooperative Group2 个研究点 分布在 1 个国家开始时间: 2003年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining celecoxib with leucovorin, fluorouracil, and oxaliplatin in treating patients who have metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic colorectal cancer treated with celecoxib, leucovorin calcium, fluorouracil, and oxaliplatin.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the time of disease control to evaluate progression-free survival in patients treated with this regimen.
- Determine the salvage surgery rate in patients treated with this regimen.
- Determine the duration of chemotherapy-free intervals in patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
- Determine the quality of life of patients 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the colon or rectum
- •Metastatic disease
- •Inoperable disease (i.e., not suitable for complete carcinological surgical resection)
- •Measurable disease or nonmeasurable disease
- •At least 1 unidimensionally measurable lesion at least 20 mm by conventional CT scan OR 10 mm by spiral CT scan
- •Nonmeasurable disease defined as all other lesions, including small lesions or truly nonmeasurable disease
- •No CNS metastases
- •No exclusive bone metastases
- •No symptomatic ascites or pleural effusion not evacuated before study entry
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No known significant bleeding disorder
- •Alkaline phosphatase less than 3 times upper limit of normal (ULN)
- •Creatinine less than 1.5 times ULN OR
- •Creatinine clearance at least 30 mL/min
- •No uncontrolled hypercalcemia
- •Cardiovascular
- •No congestive heart failure
- •Gastrointestinal
- •No total or partial bowel obstruction
- •No active gastric or duodenal ulceration or gastrointestinal bleeding within the past year
- •No active inflammatory bowel disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •No peripheral sensory neuropathy
- •No known sensitivity to celecoxib, other COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides
- •No AIDS-related illness
- •No active infection
- •No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior immunotherapy for metastatic disease
- •Chemotherapy
- •Prior adjuvant chemotherapy allowed provided the progression-free interval after completion of therapy is more than 6 months in duration
- •No prior chemotherapy for metastatic disease
- •No prior adjuvant oxaliplatin
- •No other concurrent chemotherapy
- •Endocrine therapy
- •No concurrent chronic oral or IV corticosteroid use (i.e., 2 weeks or longer in duration)
- •Radiotherapy
- •No concurrent radiotherapy
- •Not specified
- 另有 7 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate
次要结局
- Toxicity
- Time of disease control (progression-free survival)
- Salvage surgery rate
- Duration of chemotherapy-free intervals
- Tolerability
- Quality of life
研究者
研究点 (2)
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