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)
Inclusion Criteria:
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 CT
scan or MRI
- 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 ≥ 3,000/mm3 with neutrophils ≥ 1,500/mm3, platelet count ≥
100,000/mm3, hemoglobin ≥ 5.6 mmol/L (9 g/dL)
- Total bilirubin ≤ 1.5 x upper reference range
- AST ≤ 2.5x upper reference range, or ≤ 5x upper reference range in case of liver
metastasis
- Serum creatinine ≤ 1.5x upper reference range
- Recovery from relevant toxicity to previous treatment before study entry
- KRAS wild-type status of tumor tissue
Exclusion Criteria:
- 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-VEGF therapy, or
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 ß-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