An Asia Pacific Non-randomized, Open-label Phase II Study Evaluating the Safety and Efficacy of FOLFIRI Plus Cetuximab (Erbitux) or FOLFOX Plus Cetuximab as First-line Therapy in Subjects With KRAS Wild-type Metastatic Colorectal Cancer (APEC-Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With Best Overall Confirmed Response Rate (BORR)
研究概览
简要总结
This is an open-label, non-randomized, multicenter Phase II study evaluating folinic acid + fluorouracil + irinotecan (FOLFIRI) plus cetuximab (Erbitux) or folinic acid + fluorouracil + oxaliplatin (FOLFOX) plus cetuximab as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
Only subjects with k-ras oncogene (KRAS) wild-type tumors are eligible. Efficacy will be assessed every 8 weeks. Treatment will be continued until progressive disease or unacceptable adverse events occur. After the end of study treatment, information on further anticancer treatment and survival will be collected every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Signed written informed consent
- •Inpatient or outpatient subjects, 18 years of age
- •Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- •Metastatic disease (M1)
- •Life expectancy of at least 12 weeks
- •Presence of at least 1 measurable index lesion (not lie in an irradiated area) by computed tomography (CT) scan or magnetic resonance imaging (MRI)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry
- •Effective contraception for both male and female subjects if the risk of conception exists
- •White blood cell count greater than or equal to (>=) 3,000 per cubic millimeter (/mm^3) with neutrophils >=1,500/mm3, platelet count >=100,000/mm3, hemoglobin >=5.6 millimole per liter (mmol/L) (9 gram per deciliter [g/dL])
- •Total bilirubin less than or equal to (<=) 1.5 x upper reference range
- •Aspartate aminotransferase (AST) <=2.5 x upper reference range, or <=5 x upper reference range in case of liver metastasis
- •Serum creatinine <=1.5 x upper reference range
- •Recovery from relevant toxicity to previous treatment before study entry
- •KRAS wild-type status of tumor tissue
排除标准
- •Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated >6 months before the start of treatment in this study
- •Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of treatment in this study
- •Concurrent chronic systemic immune therapy, targeted therapy, anti-vascular endothelial growth factor (VEGF) therapy, or epidermal growth factor receptor (EGFR-) pathway targeting therapy not indicated in this study protocol
- •Concurrent hormone therapy not indicated in this study protocol except for physiologic replacement or contraception
- •Known hypersensitivity reaction to any of the components of study treatments
- •Pregnancy (absence to be confirmed by beta human choriongonadotrophin [beta-hCG] test) or lactation period
- •Brain metastasis and/or leptomeningeal disease (known or suspected)
- •Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
- •Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- •Peripheral neuropathy > grade 1
- •Previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
- •Known alcohol or drug abuse
- •Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
- •Participation in another clinical study within the past 30 days
- •Significant disease which, in the investigator's opinion, would exclude the patient from the study
- •Legal incapacity or limited legal capacity
- •KRAS mutated status of tumor tissue
研究组 & 干预措施
Cetuximab plus FOLFIRI
干预措施: Cetuximab (Drug)
Cetuximab plus FOLFIRI
干预措施: FOLFIRI (Drug)
Cetuximab plus FOLFOX
干预措施: Cetuximab (Drug)
Cetuximab plus FOLFOX
干预措施: FOLFOX (Drug)
结局指标
主要结局
Percentage of Subjects With Best Overall Confirmed Response Rate (BORR)
时间窗: From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited until data cut-off date (31 May 2012)
Response rate was defined as the percentage of subjects with BORR (confirmed complete response \[CR\] or partial response \[PR\]) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. As per RECIST v 1.0 criteria for target lesions and assessed by magnetic resonance imaging (MRI): CR = disappearance of all target lesions; PR = at least 30 percent (%) decrease in the sum of the longest diameter of target lesions. Response rate will be assessed every 8 weeks.
次要结局
- Overall Survival (OS) Time(From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014))
- Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and TEAEs Leading to Death(From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014))
- Progression-Free Survival (PFS) Time(From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014))