Phase II Study of Avastin Plus Erbitux Plus Irinotecan as 2nd Line Treatment of Locally Advanced or Metastatic Colorectal Cancer in Patients Achieving Disease Progression as Best Response After 1st Line Treatment With FOLFIRI+Avastin or XELIRI+Avastin
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 8
- 主要终点
- Time To Progression
研究概览
简要总结
This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.
详细描述
Treating patients with primary resistance to the most active multi-agent combination remains a challenging clinical problem. The reported data demonstrated that addition of ERBITUX may reverse IRINOTECAN resistance. Further data support the feasibility of the combination of two monoclonal antibodies (AVASTIN+ERBITUX) with IRINOTECAN with better responses compared to historical controls (ERBITUX±IRINOTECAN). As such, a phase II study was designed to evaluate the efficacy of the combination of AVASTIN plus ERBITUX plus IRINOTECAN as second line treatment in patients progressing while on treatment with FOLFIRI AVASTIN or XELIRI AVASTIN
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally advanced or metastatic colorectal cancer.
- •Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- •ECOG performance status ≤ 2
- •Age 18 - 72 years
- •Patients with de novo refractory disease (progression of disease as best response at 1st line therapy with FOLFOX/Avastin)
- •Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL),renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
- •Patients must be able to understand the nature of this study
- •Written informed consent
排除标准
- •History of serious cardiac disease (unstable angina, congestive heart failure, uncontrolled cardiac arrhythmias).
- •History of myocardial infarction or stroke within 6 months.
- •Clinically significant peripheral vascular disease.
- •History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day
- •Presence of central nervous system or brain mets.
- •Evidence of bleeding diathesis or coagulopathy.
- •Patients with known hypersensitive reaction to cetuximab
- •Blood pressure > 150/100 mmHg.
- •Pregnant or lactating woman.
- •Life expectancy < 3 months.
- •Previous radiotherapy within the last 4 weeks or > 25% of bone marrow.
- •Metastatic infiltration of the liver >50%.
- •Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy.
- •Active infection requiring antibiotics on Day
- •Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
- •Psychiatric illness or social situation that would preclude study compliance.
研究组 & 干预措施
1
Irinotecan+Avastin+Erbitux
干预措施: Irinotecan (Drug)
1
Irinotecan+Avastin+Erbitux
干预措施: Avastin (Drug)
1
Irinotecan+Avastin+Erbitux
干预措施: Erbitux (Drug)
结局指标
主要结局
Time To Progression
时间窗: 1 year
次要结局
- Objective Response Rate(Objective responses confirmed by CT or MRI (on 3rd and 6th cycle))
- Toxicity profile(Toxicity assessment on each chemotherapy cycle)
- Quality of life, Symptoms improvement(Assessment every two cycles)