Exploratory Phase II Clinical Trial Comprising Biomarker Analysis of Oxaliplatin Plus Fluorouracil/Leucovorin (FOLFOX) in Combination With Bevacizumab (Bvz) in First Line Treatment of Metastatic Colorectal Cancer (CRC) Expressing Mutant K-ras - AC-ANGIOPREDICT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 17
- 主要终点
- Identification of biomarkers
研究概览
简要总结
Primary Objective:
The primary objective is to validate previously identified predictive/prognostic genomic DNA and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced CRC (a CRC) or metastatic CRC (mCRC).
Secondary Objective:
- To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed advanced or metastatic K-ras mutant CRC and
- To determine the progression free and overall survival of patients under first line FOLFOX + bvz in aCRC or mCRC.
详细描述
Study Design:
Type of Study: Exploratory, translational, multicenter and multinational Phase II study.
Patient Population:All patients from the intent-to-treat population with aCRC or mCRC, (incurable with any conventional multimodality approach) and who fulfil all inclusion and exclusion criteria.
Number of Patients: 224
Sample Type:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients ≥ 18 years of age.
- •Patients diagnosed with recurrent or de novo, locally advanced (unresectable) or metastatic adenocarcinoma of the colon or rectum.
- •Planned combination bevacizumab (bvz) treatment with either:
- •leucovorin, fluorouracil and oxaliplatin (FOLFOX)
- •capecitabine and oxaliplatin (XELOX)
- •leucovorin, fluorouracil and irinotecan (FOLFIRI)
- •capecitabine and irinotecan (XELIRI)
- •Naive for bvz
- •An evaluable site of disease
- •ECOG Performance status 0, 1, or 2
- •Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN or GFR ≥ 50ml/min
- •Adequate hematopoietic function [white blood cell (WBC) count ≥ 3000/μl, absolute neutrophil count (ANC) ≥1500/μl, platelets ≥100 000/μl, haemoglobin level ≥ 9.0 g/dl]
- •Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 3.0 x ULN (in case of liver metastases SGOT and SGPT < 5.0 x ULN)
- •Ability to give signed informed consent prior to any screening procedures
- •FFPE Tissue is available
排除标准
- •Patient has received any other investigational product within 28 days of first day of study drug dosing
- •Patients having familial and/or hereditary CRC
- •CRC associated with ulcerative colitis
- •Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
研究组 & 干预措施
Intent-to-treat population with aCRC or mCRC
Advanced Colorectal Cancer with planned treatment with a aCRC or mCRC and who fulfil all inclusion and exclusion criteria
干预措施: Biomarker analysis (Other)
结局指标
主要结局
Identification of biomarkers
时间窗: 4 years
Identification of biomarkers, which are predictive for response and/or prolonged PFS to FOLFOX/bvz combination therapy in aCRC or mCRC patients.
次要结局
- Validation of identified biomarkers(4 years)