A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- To evaluate the efficacy (measured by time to progression) of oxaliplatin, capecitabine, and bevacizumab as first-line therapy in elderly patients with metastatic colorectal cancer.
研究概览
简要总结
Currently there is no one standard of care for older patients with metastatic colorectal cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus bevacizumab. The study will also gather information on the usefulness and side effects of this treatment combination.
详细描述
Colorectal cancer is primarily a disease of the elderly, with the median age in the United States of 70 years. Age greater than 65 years at presentation is not a contraindication to standard therapies; acceptable morbidity and mortality, as well as long term survival, are achieved in this patient population. However, studies evaluating combination therapy have generally involved younger patients with high performance status scores. Given the non-over-lapping safety profiles of the proposed study agents and the potential synergy, it would be of benefit to explore the combination of oxaliplatin, capecitabine, and bevacizumab in the treatment of older patients with colorectal cancer. Time to progression, overall response, duration of response, and toxicity profile will be evaluated. The feasibility of using a self-report geriatric assessment tool will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years and above;
- •Histologically or cytologically documented adenocarcinoma of the colon or rectum;
- •Metastatic disease;
- •Measurable disease or assessable but nonmeasurable disease allowed;
- •No prior oxaliplatin or bevacizumab.
- •No prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy allowed;
- •No prior fluoropyrimidine therapy (unless give in an adjuvant setting and completed at least 4 months earlier);
- •No bleeding diathesis or coagulopathy
- •Adequate renal and hepatic functions as per protocol;
- •Signed informed consent
排除标准
- •Clinically significant cardiovascular or peripheral vascular disease;
- •Concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or therapeutic heparin;
- •Serious non-healing wound, ulcer, or bone fracture;
结局指标
主要结局
To evaluate the efficacy (measured by time to progression) of oxaliplatin, capecitabine, and bevacizumab as first-line therapy in elderly patients with metastatic colorectal cancer.
次要结局
- Overall response
- Duration of response
- Safety and tolerability (NCI CTCAE v3.0, discontinuations, dose intensity)
- Vulnerable Elders Survey (VES-13) and Geriatric Depression Scale (GDS) scores