Clinical trial NCT00866944: Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Metastases
Colorectal Cancer
Keywords: Colorectal carcinoma
Liver metastases (only)
R0 resection
R0 resection of liver metastases from colorectal cancer
Lead sponsor: Amgen Research (Munich) GmbH
Sponsor class: INDUSTRY
First posted: 2009-03-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Disease free survival rate (DFS)
timeFrame: 1 year
Secondary outcomes:
measure: time to relapse
timeFrame: 1 year
measure: Incidence of AEs
timeFrame: 1 year
measure: Quality of Life
timeFrame: 1 year
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Augsburg
country: Germany
facility: Zentralklinikum Augsburg
city: Bamberg
country: Germany
facility: Klinikum am Bruderwald, Sozialstiftung Bamberg
city: Berlin
country: Germany
facility: Charité Campus Virchow Klinikum
city: Düsseldorf
country: Germany
facility: Klinikum der Heinrich-Heine Universität
city: Frankfurt
country: Germany
facility: J.W. Goethe-Universität
city: Halle
country: Germany
facility: Martin-Luther Universität
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg gGmbH
city: Mainz
country: Germany
facility: Klinikum der Johannes-Gutenberg Universität
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH Universitätsklinikum
city: München
country: Germany
facility: Universitätsklinikum der LMU Grosshadern
city: München
country: Germany
facility: Städtisches Klinikum Neuperlach
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg gGmbH
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
Study officials:
affiliation: Charité Campus Virchow Klinikum, Berlin
name: Peter Neuhaus, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Paul Strauss, Strasbourg
name: Patrick Dufour, Pr. Dr.
role: PRINCIPAL_INVESTIGATOR
References: