First-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer 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: C225
Concentration unit:
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 lie in an irradiated area) ECOG performance status of =2 at study entry Effective contraception for both male and female patients if the risk of conception exists White blood cell count =3 x 10E9/L with neutrophils =1.5 x 10E9/L, platelet count =100 x 10E9/L, hemoglobin =5.6 mmol/L (9 g/dL) Total bilirubin =1.5 x upper reference range· 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. 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 targeting therapy Previous irinotecan-based chemotherapy 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 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 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 preinvasive cancer of the cervix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the progression-free survival time under 5-FU/FA plus irinotecan plus cetuximab is longer than that under 5-FU/FA plus irinotecan as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer.;Secondary Objective: To compare between the 2 treatment groups for: Overall survival time Response rate (modified WHO criteria) Disease control rate To determine: Duration of response Quality of life (EORTC QLQ-C30 Questionnaire) Safety.;Primary end point(s): Progression free survival | — |
Countries
Czech Republic, Estonia, Finland, Hungary, Italy, Lithuania, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed