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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00860860
Eligibility Criteria:
Inclusion Criteria:
* Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available
* WHO performance status: 0 or 1
* Having normal hematological function: Neutrophils \> 1.5 x 109/l; Platelet count \> 150 x 109/l, without transfusion during the previous month; Hemoglobin \> 5.6 mmol/l
* Total bilirubin \< 2 x upper limit of normal (ULN)
* ASAT, ALAT \< 3 x ULN
* Serum creatinine \< 2 x ULN
* Cockcroft clearance \> 50 ml/min
* Negative pregnancy test for women of child¬bearing potential (urine or serum)
* Age over 18 years
* Ability to provide written informed consent
Exclusion Criteria:
* Known metastases to the brain
* Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.
* Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks
* Cardiac disease with New York Heart Association classification of III or IV
* Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
* Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status
* Life expectancy shorter than 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00860860
Study Brief:
Protocol Section:
NCT00860860