A Randomized, Open-label, Controlled, Multi-center Phase II Study to Evaluate the Efficacy and Safety of Adecatumumab Alone or Sequentially to FOLFOX Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases
Inclusion Criteria:
- Histopathologically confirmed complete resection (R0) of liver metastases from
colorectal adenocarcinoma
- Age ≥18 years
- ECOG performance status ≤ 2
- Patient was informed, has read and understood the patient information / informed
consent form and has given written informed consent
Exclusion Criteria:
- Extra-hepatic distant metastases or locally recurrent disease at time of enrolment
- Neoadjuvant chemotherapy of liver metastases prior to surgery
- Any anticancer chemotherapy within 4 weeks prior to study entry
- Start of Oxaliplatin-based chemotherapy within 9 months prior to study entry
- Any biological anticancer therapy or immunotherapy within 4 weeks prior to study
entry
- Any radiotherapy or radio frequency ablation (RFA) to the liver prior to surgery
- Treatment with any investigational product within a time range of 4-5 half-lives (t½)
prior to study entry
- Acute or chronic pancreatitis or history of alcohol induced pancreatitis
- Liver cirrhosis, acute hepatitis or chronic hepatic disease
- Any unresolved complications from prior surgery
- Persistent neuropathy
- History of other malignancy within 5 years prior to study start, with the exception
of basal cell carcinoma of the skin, carcinoma in situ of the cervix and Ductal
Carcinoma in Situ (DCIS)
- History of inflammatory bowel disease
- Active severe infection, any other concurrent disease or medical condition that is
deemed to interfere with the conduct of the study as judged by the investigator
- Use of immune-suppressive agents such as the regular use of systemic corticosteroids
- HIV positivity
- Known hypersensitivity or intolerability to immunoglobulins in general, other
recombinant human or humanized antibodies, Folinic Acid, 5-Fluorouracil, Oxaliplatin
or a component of the study drug formulations, known dihydropyrimidine dehydrogenase
(DPD) deficiency
- Pregnant or nursing women
- Women of childbearing potential or male patients not willing to use an effective form
of contraception during treatment phase of the study and at least 6 months thereafter
- Not willing or incapable to comply with all study visits and assessments
- Placed into an institution due to juridical or regulatory ruling