Patients with metastatic colorectal cancer (MCC). MedDRA version: 9.1 Level: LLT Classification code 10010029 Term: Colorectal cancer NOS
Conditions
Interventions
Product Name: Cetuximab
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Co
Sponsors
Universith Hospital of Heraklion, Department of Medical Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients with histologically proven metastatic adenocarcinoma of the colon or rectum •Previous chemotherapy for metastatic disease not allowed. Patients who received prior adjuvant 5-FU-based chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy. •Patients with operable metastatic disease are excluded from the study. •Age 18-70 years •Performance status (ECOG) 0-1 •At least one bidimensionally measurable lesion of ? 2cm; •Life expectancy of at least 6 months •Adequate hematologic parameters (absolute neutrophil count ? 1.5x109/L and platelets ? 100x109/L); creatinine and total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Absence of active infection or malnutrition (loss of more than 20% of the body weight) •No history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated •Patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields. •Patients with severe cardiac dysfunction, liver metastases involving more than 50% of the liver parenchyma, chronic diarrhea, or prior irradiation affecting more than 30% of the active bone marrow are excluded. •All patients will have to sign written informed consent in order to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Objective Response Rate;Secondary Objective: •Resectability rates •Time to Tumor Progression (TTP), median Overall Survival (mOS) •Toxicity profile •Pharmacogenomic analysis •Q-Twist analysis of Quality of life ;Primary end point(s): •Objective Response Rate | — |
Countries
Greece
Outcome results
None listed