NCT00043199Unknown2 期
A Phase II Study of Aroplatin in Subjects With Recurrent, Unresectable and Metastatic Colorectal Cancer Refractory to 5-Fluorouracil (5-FU)/Leucovorin or Capecitabine, and Irinotecan
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 4
研究概览
简要总结
To determine the rate of response and duration of reponse following therapy with Aroplatin in subjects with advanced colorectal cancer resistant to standard therapies. Secondary objectives are to determine safety and tolerability of the Aroplatin therapy.
详细描述
Primary Objective:
- To determine response rate (RR; complete and partial response[CR,PR] and duration after therapy with Aroplatin (Liposomal NDDP, L-NDDP) in subjects with locally recurrent, unresectable or metastatic colorectal cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan.
Secondary Objective:
- To determine safety and tolerability of the Aroplatin therapy.
This is a single-arm, open-label phase II study. Subjects refractory to 5-FU/leucovorin or capecitabine, and irinotecan therapies will be enrolled. Dosing will be every four weeks with individual dose escalations and adjustments for toxicity.
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
- •Colorectal cancer, locally recurrent, unresectable or metastatic disease (AJCC);
- •Measurable disease (RECIST criteria);
- •Cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan;
- •ECOG performance score of 0-2;
- •Adequate hematopoietic, liver and renal function;
- •Adequate cardiac function (maximum of class II, NYHA);
- •Women of child-bearing potential must have a negative urine or serum pregnancy test;
- •Signed written informed consent;
- •Subjects must be willing to to be followed during the course of treatment/observation and follow-up.
排除标准
- •Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;
- •Pregnant or breast feeding subjects, or male or female subjects of child producing potential who will not agree to use adequate contraception during the treatment phase of the study;
- •Prior therapy with oxaliplatin;
- •Known brain metastases;
- •Active, uncontrolled infection or other serious medical illnesses;
- •Subjects may not be using or have used any investigational therapy during four weeks before start of the protocol treatment.
研究者
研究点 (4)
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