Phase I Clinical Study of the Feasibility of Pretargeted Radioimmunotherapy of an Anti-CEA Bispecific Antibody and Lu-177-labeled Peptide in Patients With Advanced Colorectal Cancer
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 childĀ¬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.