NCT00129870终止4 期
CONCEPT - Phase IV, Randomized, Prospective, Multicenter Comparison of Intermittent Schedule of Oxaliplatin Combined With FOLFOX/Bevacizumab vs Conventional Mode of Administration of FOLFOX/Bevacizumab + Neuroprophylaxis With Calcium/Magnesium for Optimization of First-Line Therapy of Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Time to treatment failure (TTF) for the conventional oxaliplatin (CO) schedule in comparison with the intermittent oxaliplatin (IO) schedule
研究概览
简要总结
The primary rationale for this study is to develop an optimized schedule of administration of FOLFOX + bevacizumab that maximizes the efficacy and safety of this regimen when administered to patients with advanced colorectal cancer. The hypothesis is that the use of an intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow these patients to continue on treatment for a longer period of time by reducing the proportion of patients who discontinue therapy early because of treatment-related toxicities and thus increasing the possibility of a longer time to progression.
The primary objective is:
- To test the hypothesis that an intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow patients to remain on therapy for a longer period of time compared to a conventional "treat-to-failure" schedule, by reducing the proportion of patients who discontinue therapy for treatment-related toxicities.
The secondary objectives are:
- To evaluate the impact of calcium/magnesium infusions on the incidence and severity of neurotoxicity in subjects receiving either the IO or conventional FOLFOX/bevacizumab treatment schedules as first-line treatment for metastatic colorectal cancer.
- To evaluate the safety and efficacy of the IO versus the conventional schedule + calcium and magnesium infusions, as part of oxaliplatin-based first-line therapy for metastatic colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Histologically or cytologically documented metastatic, measurable adenocarcinoma of the colon, rectum, or appendix with no prior therapies for metastatic disease
- •ECOG performance status (PS) of 0 or 1
- •Adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters
- •No other serious concomitant disease.
排除标准
- •Peripheral neuropathy > Grade 1 at baseline
- •History of significant cerebrovascular, cardiovascular, or peripheral vascular disease
- •Uncontrolled hypertension (defined as blood pressure > 150/100 mmHg)
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess, within 6 months prior to start of study drug
- •Minor surgical procedure, fine needle aspiration, or core biopsy within 7 days prior to start of study drug
- •Serious, non-healing wound, ulcer, or bone fracture
- •Active gastroduodenal ulcer
- •Evidence of bleeding diathesis or coagulopathy
- •Significant history of bleeding within 6 months prior to registration
- •Prior history of hypertensive crisis or hypertensive encephalopathy
结局指标
主要结局
Time to treatment failure (TTF) for the conventional oxaliplatin (CO) schedule in comparison with the intermittent oxaliplatin (IO) schedule
次要结局
- The incidence of adverse events, including neurotoxicity, as determined using the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0 (CTCAE v3.0)
- Quality of life, including oxaliplatin-specific neurologic symptoms determined using the PNQoxali
- Tumor response rate (overall and confirmed) based on application of the Response Evaluation Criteria in Solid Tumors (RECIST)
- Time to tumor progression (TTP)
- Time of tumor control (TTC)
- Overall survival (OS)
- Reasons for treatment discontinuation
研究者
研究点 (2)
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