first-line treatment of metastatic colorectal cancer
Conditions
Interventions
Trade Name: Erbitux
Product Name: Cetuximab
Product Code: EMD271786
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Cetuximab
Current Sponsor code: EMD271786
Concentration unit: mg/ml m
Sponsors
Technical University Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, all of the following inclusion criteria must be fulfilled: - Diagnosis of non-resectable, histologically confirmed, EGFR positive or negative colorectal cancer - WHO PS 0 or 1 - Signed written informed consent - =18 years of age - Effective contraception for both male and female subjects if the risk of conception exists - Adequate bone marrow function: Neutrophiles blood cell count (NBC) = 1,5x109/L, platelet count = 100x109/L, hemoglobin = 5.96 mmol/L (10 g/dL) - Adequate liver and renal function: bilirubin = 1,5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks, ASAT and ALAT = 5 x UNL. Serum creatinine = 1.5 x UNL. 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: Subjects are not eligible for this study if any of the following exclusion criteria apply: - Previous exposure to epidermal growth factor receptor-targeting therapy - Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment or 5-FU in combination with radiotherapy for rectal cancer - Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before inclusion. - Concurrent chronic systemic immune therapy, chemotherapy or hormone therapy. - Investigational agents or participation in clinical trials within 30 days before start of the treatment in study. - Clinically relevant coronary disease or myocardial infarction within 12 months before study entry. - Peripheral neuropathy > CTC grade I - Inflammatory bowel disease - Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment) - History of severe psychiatric illness - Drug or alcohol abuse - Known hypersensitivity reaction to any of the components of study treatments - Pregnancy (absence to be confirmed by b-hCG test) or lactation period - Brain metastasis and/or leptomeningeal disease (known or suspected) - Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective To assess a maximal tolerable dose of a chemotherapy-combination of Cetuximab, Irinotecan, Oxaliplatin and 5-FU/ Folinic acid as first-line treatment for metastatic colorectal cancer. ;Secondary Objective: Secondary Objectives To assess the treatment regarding the following: · feasibility · toxicity · response rate · resection rate · progression free and overall survival ;Primary end point(s): To assess a maximal tolerable dose of a chemotherapy-combination of Cetuximab, Irinotecan, Oxaliplatin and 5-FU/ Folinic acid as first-line treatment for metastatic colorectal cancer. | — |
Countries
Germany
Outcome results
None listed