In Denmark there is approximately 3600 new cases of Colorectal cancer every year. In Denmark about half of these patients will eventually develop metastatic disease. In Denmark it is suggested that 150 patients each year will be in such good performance to third line chemotherapy. MedDRA version: 9 Level: 1.0 Classification code 10010029
Conditions
Interventions
Trade Name: Erbitux
Product Name: Cetuximab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concen
Sponsors
Department of Oncology, University Hospital Herlev
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient with histological proven MCRC. 2. Patients must have measurable disease, according to RECIST criteria. 3. Irinotecan resistant disease i.e. progressive disease after at least 6 weeks of therapy with Irinotecan-containing therapy or within 3 months thereafter. 4. Age =18 years. 5. Performance status (WHO) of 0-2. 6. Patient must have a life expectancy of at least 3 months. 7. Adequate hematological function defined ANC ³1.5 x 109/l 1. Patient with histological proven MCRC. 2. Patients must have measurable disease, according to RECIST criteria. 3. Irinotecan resistant disease i.e. progressive disease after at least 6 weeks of therapy with Irinotecan-containing therapy or within 3 months thereafter. 4. Age =?18 years. 5. Performance status (WHO) of 0-2. 6. Patient must have a life expectancy of at least 3 months. 7. Adequate hematological function defined ANC ³1.5 x 109/l and platelets =100 x 109/l . 8. Adequate liver function defined as Bilirubin = 1,5 x UNL (upper normal limit) and/or ASAT/ALAT = 5 x UNL. 9. All should have been exposed to Oxaliplatin-containing therapy. 10. Written informed consent must be obtained according to the local Ethics Committee requirements. platelets 100 x 109/l . 8. Adequate liver function defined as Bilirubin = 1,5 x UNL (upper normal limit) and/or ASAT/ALAT = 5 x UNL. 9. All should have been exposed to Oxaliplatin-containing therapy. 10. Written informed consent must be obtained according to the local Ethics Committee requirements. 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: 1. Previous or some other concomitant malignancy, with the exception of adequately treated basal cell skin cancer or in situ cervical cancer. 2. Inability to follow the treatment and evaluation schedule. 3. Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives. 4. Pregnant or lactating women. In fertile women this is ensured by a negative pregnancy test or use of safe antikonception (as defined by the Danish medicines agency during the study period and at least 3 months thereafter. 5. Patients with active infections or other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment. 6. Known hypersensitivity to any of the components of the treatment. 7. Legal incapacity. 8. Reduced liver function defined by bilirubin > 5 x UNL or ASAT/ALAT > 5xUNL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall response rate. ;Secondary Objective: To evaluate and determine · Time to progression after 1.day of start of therapy. · Overall survival from date start of therapy. · Safety and toxicity of the treatment · Influence of smoking on response to therapy, OS and TTP and other parameters investigated in the protocol. · Predictability of metabolic response as evaluated by a PET-scan two weeks after initiation of treatment (optional) on response to therapy, OS and TTP and other parameters investigated in the protocol. · The relation between potentially predictive and prognostic tumor biomarkers ;Primary end point(s): Overall response rate. | — |
Countries
Denmark
Outcome results
None listed