Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX alone.

Official Title
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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
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Liver Metastases, Colorectal Cancer

Intervention / Treatment
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* Drug: Adecatumumab
* Drug: Adecatumumab and FOLFOX
* Drug: FOLFOX 4


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Adecatumumab alone | Drug: Adecatumumab<br>* Adecatumumab,6-9mg/kg, every 14 days, 24 cycles<br>* Other names: MT201;|
| Experimental: 2<br>FOLFOX 4 followed by Adecatumumab | Drug: Adecatumumab and FOLFOX<br>* FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles<br>|
| Active Comparator: 3<br>FOLFOX 4 alone | Drug: FOLFOX 4<br>* FOLFOX 4, every 14 days, 12 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival rate (DFS) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to relapse |  | 1 year | 
| Incidence of AEs |  | 1 year | 
| Quality of Life |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal carcinoma, Liver metastases (only), R0 resection, R0 resection of liver metastases from colorectal cancer