R0 resected liver metastases from colorectal cancer
Conditions
Sponsors
Micromet AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 2 4. Ability to understand and willingness to sign a 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 Gpt/l (2x109/l, 2000/mm³) 3. Blood coagulation at time of treatment start as defined below: a. INR =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of the monoclonal AB adecatumumab alone or sequentially to FOLFOX on 1 year disease-free survival (DFS) rates in colorectal cancer patients with complete (R0) resection of liver metastases ;Primary end point(s): One year disease free survival (DFS) rate, defined by the ratio of disease-free patients one year after randomization to total patients per treatment arm;Secondary Objective: •To assess the 1 year disease-free survival (DFS) rate after treatment with FOLFOX. •To compare 1 year disease-free survival (DFS) rate of the treatment with the monoclonal AB adecatumumab alone or sequentially to FOLFOX to treatment with FOLFOX. •To assess the disease free survival (DFS) of patients in the three treatment arms at 2 and 3 years after randomization. •To assess the time-to-relapse (TTR) and relapse rates for patients in the three treatment arms. •To assess the safety profile in the three treatment arms. •To assess the quality of life for the three treatment arms. | — |
Countries
France, Germany
Outcome results
None listed