A Phase I/II Clinical Trial of Combination of Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen With Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Phase I: Assess the MTD and RD for phase II of IXO and bevacizumab combination given every 3 weeks in 1st line patients with mCRC
研究概览
简要总结
Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are associated with high response rates and long survival as first-line treatment for metastatic colorectal cancer (mCRC). The oral fluoropyrimidine, capecitabine, is better tolerated and shows better response rates than 5-FU/LV in metastatic colorectal cancer. A phase I dose-escalation study established dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II doses (RPIID) of irinotecan, oxaliplatin and capecitabine. This phase I /II study is to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), phase II recommended dose (RD) of IXO and bevacizumab combination and safety at the RD in an expanded cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically documented adenocarcinoma of the colon or rectum.
- •Advanced and/or metastatic disease, incurable with standard therapy.
- •Unresectable advanced and/or metastatic unidimensionally measurable disease (RECIST scale).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •Age: over 18 years.
- •Adequate haematological, renal and hepatic functions
- •Patient consent must be obtained according to local REB requirements.
- •Patients must be accessible for treatment and follow up.
排除标准
- •Previous or concurrent malignancies
- •Pregnant or lactating women. Women of childbearing potential must have had a negative pregnancy test within 7 days prior to registration.
- •Concurrent treatment with other experimental drugs or anticancer therapy.
- •Previous chemotherapy for advanced and/or metastatic disease.
- •Previous adjuvant therapy with irinotecan or oxaliplatin.
- •Previous full dose curative pelvic radiation therapy.
- •Patients with documented brain metastases.
- •Serious illness or medical condition.
- •Gilbert's disease
- •Use of enzyme inducing anticonvulsants such as phenytoin, phenobarbital and carbamazepine
研究组 & 干预措施
IXO regimen + bevacizumab
This is phase I/II safety and efficacy study. There is only one arm of Irinotecan, Xeloda and Oxaliplatin (IXO) regimen with Avastin (bevacizumab)
干预措施: IXO regimen + bevacizumab (Drug)
结局指标
主要结局
Phase I: Assess the MTD and RD for phase II of IXO and bevacizumab combination given every 3 weeks in 1st line patients with mCRC
时间窗: 3-week cycle, continuous monitoring of AE
Phase II: Using the RD established in phase I, assess efficacy of the IXO with bevacizumab combination as measured by progression-free survival
时间窗: 3-week cycle, continuous monitoring of AE
次要结局
- Overall survival(continuous)
- Qualitative and quantitative toxicity(continuous)
- Response rates and duration of response(every 2 cycles - 6 weeks)