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

Conditions: R0 resected liver metastases from colorectal cancer

Registration Number: EUCTR2008-004706-14-DE

Lead Sponsor: Micromet AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

1. Histopathologically confirmed complete resection (R0) of liver metastasis(es) from colorectal adenocarcinoma (additional confirmation by CT scan at treatment start)
2. Age =18 years
3. ECOG performance status smaller or equal then 2
4. Patient was informed, has read and understood the patient information / informed consent form and has given written informed consent

The following eligibility criteria must be fulfilled before the patient can be treated with study medication:

1. CT confirmation of complete resection (R0) of liver metastasis(es) (and histopathological confirmation of tumor-free margin)
2. Organ or bone marrow function at time of treatment start as defined below:
a.WBC > 3 Gpt/l (3x109/L, 3000/mm3)
b.Platelet count > 100 Gpt/l (100x109/L, 100,000/mm³)
c.Creatinine clearance = 50 ml/min (calculated e.g. according to MDRD)
d.Serum bilirubin < 2 x upper limit of normal (ULN)
e.AST (SGOT)/ALT (SGPT) = 5 x upper limit of normal (ULN)
f.Serum lipase = 1.5 x upper limit of normal (ULN)
g.Neutrophiles > 2Gpt/l (2x109/l, 2000/mm3)
3. Blood coagulation at time of treatment start as defined below:
a.INR < 1.5 x upper limit of normal (exception: patient receives therapeutic anticoagulation)
b.PTT < 1.5 x upper limit of normal(sec)
4. Investigator’s discretion that the clinical condition of the patient allows start of treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Extra-hepatic distant metastases or locally recurrent disease at time of enrolment
2. Neoadjuvant chemotherapy for liver metastases prior to surgery
3. Any anticancer chemotherapy within 4 weeks prior to study entry
4. Start of Oxaliplatin-based chemotherapy within 9 months prior to study entry
5. Any biological anticancer therapy or immunotherapy within 4 weeks prior to study entry
6. Any radiotherapy or radio frequency ablation (RFA) to the liver prior to surgery
7. Treatment with any investigational product within a time range of 4-5 half-lives (t½) prior to study entry
8. Acute or chronic pancreatitis or history of alcohol induced pancreatitis
9. Liver cirrhosis, acute hepatitis or chronic hepatic disease
10. Any unresolved complications from surgery
11. Persistent neuropathy
12. 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)
13. History of inflammatory bowel disease
14. Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
15. Use of immune-suppressive agents such as the regular use of systemic corticosteroids
16. HIV positivity
17. 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
18. Pregnant or nursing women
19. 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
20. Not willing or incapable to comply with all study visits and assessments
21. Placed into an institution due to juridical or regulatory ruling
22. Vaccination with live vaccines (e.g. yellow fever)
23. Concomitant treatment with phenytoin