liver metastases
Conditions
Interventions
Patients will receive a single dose of cetuximab 48 hours prior to surgery in a
dose escalating fashion. Starting dose is 50mg/m2 and this will be increased to
100mg/m2, 200mg/m2, and 400mg/m2 in co
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years or older - informed consent - Presence of colorectal cancer liver metastases and patient eligible for local treatment of colorectal liver metastases - open, laparoscopic or percutaneous treatment of liver metastases, including surgical resection radiofrequent ablation, microwave ablation, irreversible electroporation or combinations of these therapies with curative intent. - no primary tumor in situ - A population EGFR/EpCAM+ tumor cells (positive for epithelial markers EpCAM and EGFR) detected in the first blood sample with flow cytometry. - Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug.
Exclusion criteria
Exclusion criteria: - Chemotherapy ( ASA 3 (American Society for Anaesthesiologists) - Expected adverse reactions/allergies for study medication - Mental disorder/unable to give informed consent - Pregnancy or breast-feeding patients - Significant skin condition interfering with treatment - Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug. - Radiotherapy to the target lesions during study or within 4 weeks of the start of study drug. - Major surgery within 28 days before start of study drug. - Substance abuse, medical, psychological or social conditions that may interfere with the subject*s participation in the study or evaluation of the study results. - Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study. - Blood transfusion during or directly after surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine whether a single neoadjuvant gift of the anti-EGFR mAb cetuximab - administered 48 hours prior to local treatment of colorectal liver metastases - reduces the number of circulating tumor cells. Furthermore, we will determine the minimal effective dose of cetuximab to do so. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are determination of the ability of plasma from patients treated with cetuximab to induce growth inhibition and antibody-dependent phagocytosis of tumor cells. Additionally, we will determine the level of EGFR expression on CTCs, the immune profile, RAS mutation status and disease free survival. | — |
Countries
Netherlands
Outcome results
None listed