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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT00784667
Eligibility Criteria:
Inclusion Criteria:
* Age\>18 years
* Histological diagnosis of colorectal cancer
* Metastatic disease not amenable to resection
* Measurable disease as assessed by CT scan using RECIST criteria
* Received and failed fluoropyrimidine therapy, where failure is defined as radiological progression after therapy for metastatic disease, prior adjuvant therapy, or toxicity limiting further therapy
* Received and failed oxaliplatin therapy, where failure is defined as radiological progression after therapy for metastatic disease, prior adjuvant therapy ,or toxicity (including neuro-toxicity) limiting further therapy
* Received and failed irinotecan therapy, where failure is defined as radiological progression after therapy for metastatic disease or toxicity limiting further therapy
* ECOG PS 0-1
* Adequate bone marrow function with platelets \> 100 X 109/l; neutrophils \> 1.5 X 109/l
* Adequate renal function, with calculated creatinine clearance \>40 ml/min (Cockcroft and Gault).
* Adequate hepatic function with serum total bilirubin \< 1.25 X upper limit of normal range and ALT or AST\<2.5xULN (\<5xULN if liver metastases present)
* Life expectancy of at least 12 weeks
* No other concurrent uncontrolled medical conditions
* No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent \>2 years previously without evidence of relapse
* Women and partners of women of childbearing potential must agree to use adequate contraception
* Written informed consent including consent for biomarker studies
Exclusion Criteria:
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol
* Prior treatment with drugs targeting EGFR such as cetuximab, panitumumab or erlotinib
* Participation in any investigational drug study within the previous 4 weeks
* Patients with uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris
* Untreated CNS metastases
* Pregnancy or lactation
* k-ras mutant tumours now excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00784667
Study Brief:
Protocol Section:
NCT00784667