Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT01051167
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven metastatic colorectal cancer
* Molecular test showing no mutation in the k-ras gene of colorectal carcinoma cells
* Male and female subjects ≥ 18 years of age
* 1st occurrence of metastatic disease (not curatively resectable)
* Life expectancy ≥ 12 weeks
* Presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at study entry
* Adequate bone marrow reserve:
leucocytes ≥ 3.0 x 109/l with neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, haemoglobin ≥ 6.21 mmol/l (10 g/dl)
* Aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT) ≤ 2.5 x upper reference range, in case of liver metastasis ≤ 5 x upper reference range
* Serum creatinine ≤ 1.5 x upper reference range
* Bilirubin ≤ 1.5 x upper reference range
* Negative pregnancy test for female and effective contraception for both male and female subjects if the risk of conception exists
* Signed written informed consent
Exclusion Criteria:
* Evidence for a mutation of the k-ras gene in the colorectal carcinoma cells
* Previous exposure to epidermal growth factor receptor-targeting therapy
* Prior chemotherapy for metastatic disease
* Prior oxaliplatin based adjuvant chemotherapy or \< 6 months after end of adjuvant treatment
* Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
* Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before registration
* Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol
* Creatinine clearance \< 30 ml/min
* Known hypersensitivity reaction to any of the components of study treatment
* Pregnancy (absence to be confirmed by ß-human chorionic gonadotropin (hCG) test) or lactation period
* 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
* Brain metastasis (known or suspected)
* Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
* Known alcohol or drug abuse
* Participation in another clinical study within the 30 days before registration
* Peripheral neuropathy \> grade 1
* Significant disease which, in the investigator's opinion, would exclude the patient from the study
* Legal incapacity or limited legal capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01051167
Study Brief:
Protocol Section:
NCT01051167