Metastatic colon rectal carcinoma MedDRA version: 7.0 Level: LLT Classification code 10052362
Conditions
Interventions
Product Name: Erbitux
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Current Sponsor code: EMD271786
Other descriptive name: Cetuximab
Concentration
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Signed written informed consents (first and second) · Inpatient or outpatient =18 years of age · Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum · 1st occurrence of metastatic disease (not curatively resectable) · Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue · Life expectancy of at least 12 weeks · Presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area) · ECOG performance status of = 2 at study entry · Effective contraception for both male and female subjects if the risk of conception exists · White blood cell count (WBC) = 3x109/L with neutrophils =1.5x109/L, platelet count > 100x109/L, hemoglobin = 6.21 mmol/L (10 g/dL) · ASAT and ALAT = 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Previous exposure to epidermal growth factor receptor-targeting therapy· Previous oxaliplatin-based chemotherapy · Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment · Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before randomization · Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol except for physiologic replacement · 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 · Previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix · Known alcohol or drug abuse· Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent· Participation in another clinical study within the 30 days before randomization · Significant disease which, in the investigator’s opinion, would exclude the subject from the study · Peripheral neuropathy > grade 1 · Legal incapacity or limited legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the rate of best confirmed response of 5-FU/FA plus oxaliplatin plus cetuximab is superior to 5-FU/FA plus oxaliplatin as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer.;Secondary Objective: To compare the 2 treatment groups regarding the following: Curative metastatic surgery Duration of response Disease control rate Progression-free survival time Overall survival time Safety and to perform a population pharmacokinetic analysis;Primary end point(s): Best confirmed response | — |
Countries
Germany, Italy, Portugal, Spain
Outcome results
None listed