Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 7
- 主要终点
- disease free survival
研究概览
简要总结
Well differentiated neuroendocrine carcinomas have low proliferative activity and conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic properties. Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing metronomic chemotherapy in this clinical setting.
A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU) infusion plus long-acting release (LAR) octreotide for patients with neuroendocrine carcinoma.
详细描述
Metastatic or locally advanced well differentiated neuroendocrine carcinoma were treated with 5Fluorouracil protracted intravenous infusion (200 mg/m2 daily) plus Octreotide LAR (20 mg monthly).
Primary Endpoint: the response to treatment, evaluated according to the RECIST criteria.
Secondary Endpoints:
- toxicity, graded according to the NCI-CTG criteria;
- symptomatic response: evaluated according to the changes in both the frequency and intensity of symptoms;
- biochemical response: evaluated considering the changes in the tumor marker levels (circulating Chromogranin A);
- time to progression and survival: were measured from the date of treatment start to the date of progression and the date of last follow-up or death, respectively.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histological diagnosis of well-differentiated neuroendocrine carcinoma according to the World Health Organization (WHO) classification;
- •locally advanced or metastatic disease not amenable to surgery with radical intent;
- •at least one measurable target lesion;
- •radiological documentation of progressive disease;
- •ECOG performance status grade <=2;
- •life expectancy >12 weeks;
- •adequate bone marrow reserve;
- •adequate hepatic and renal function;
- •ability to comply with the protocol procedures (including geographic accessibility);
- •written informed consent.
排除标准
- •non-malignant systemic disease or conditions that precluded patients from receiving the study therapy;
- •second primary malignancies and previous systemic antineoplastic treatment including somatostatin analogues;
- •history of prior malignancy, excepted for cured non-melanoma skin cancer, and cured in situ cervical carcinoma.
研究组 & 干预措施
treatment arm
continuous 5 fluouracil infusion plus long-acting octreotide
干预措施: continuous 5 fluouracil infusion plus long-acting octreotide (Drug)
结局指标
主要结局
disease free survival
时间窗: 50 months
次要结局
未报告次要终点