A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients
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Keep this study
Lead
Merck KGaA, Darmstadt, Germany
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed written informed consent (first and second)
Chinese with Chinese citizenship
Male or female subjects greater than or equal to (\>=) 18 years of age
Medically accepted effective contraception if procreative potential exists (applicable for both male and female subjects until at least 90 days after the last dose of trial treatment)
Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
First occurrence of metastatic disease (not curatively resectable) RAS wild-type status in tumor tissue
At least one measurable lesion by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST (not in an irradiated area)
Life expectancy of at least 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry
White blood cell count \>= 3 × 10x9/L with neutrophils \>= 1.5 × 10x9/L, platelet count \>= 100 × 10x9/L and hemoglobin \>= 6.21 mmol/L (10 g/dL)
Total bilirubin \<= 1.5 × upper limit of reference range
Aspartate transaminase (AST) and alanine transaminase (ALT) \<= 2.5 × upper limit of reference range or \<= 5 × upper reference range in subjects with liver metastasis
Serum creatinine \<= 1.5 × upper limit of reference range
Recovery from relevant toxicity due to previous treatment before trial entry
You may not be if
Previous chemotherapy for CRC except adjuvant treatment if terminated \> 9 months (oxaliplatin-based chemotherapy) or \> 6 months (non-oxaliplatin-based chemotherapy) before the start of treatment in this trial
Radiotherapy or surgery (excluding prior diagnostic biopsy) in the 30 days before trial treatment
Previous treatment with monoclonal antibody therapy, vascular endothelial growth factor (VEGF) pathway-targeting therapy, epidermal growth factor receptor (EGFR) pathway-targeting therapy, or other signal transduction inhibitors
History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
Renal replacement therapy
Intake of any investigational medication within 30 days before trial entry
Granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) within 3 weeks of trial entry (these growth factors may be used during the trial thereafter)
Other non-permitted concomitant anticancer therapies
Known brain metastasis and/or leptomeningeal disease. Subjects with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis
Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 5 years, or left ventricular ejection fraction below the institutional range of normal on a baseline multiple gated acquisition scan or echocardiogram
Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
Active clinically serious infections (\> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0), including active tuberculosis
Known and declared history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
Peripheral neuropathy \> grade 1
Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
Known hypersensitivity or allergic reactions against any of the components of the trial treatments
Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding
Ongoing alcohol or drug abuse
Presence of a medical or psychological condition that would not permit the subject to complete the trial or sign informed consent
Participation in another clinical trial within the past 30 days
Other significant disease that in the investigator's opinion should exclude the subject from the trial
Legal incapacity or limited legal capacity
Clareo Health | A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients
