Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases
NCT ID: NCT00866944
Last Updated: 2011-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2009-03-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Adecatumumab alone
Adecatumumab
Adecatumumab,6-9mg/kg, every 14 days, 24 cycles
2
FOLFOX 4 followed by Adecatumumab
Adecatumumab and FOLFOX
FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles
3
FOLFOX 4 alone
FOLFOX 4
FOLFOX 4, every 14 days, 12 cycles
Interventions
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Adecatumumab
Adecatumumab,6-9mg/kg, every 14 days, 24 cycles
Adecatumumab and FOLFOX
FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles
FOLFOX 4
FOLFOX 4, every 14 days, 12 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amgen Research (Munich) GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Neuhaus, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Charité Campus Virchow Klinikum, Berlin
Patrick Dufour, Pr. Dr.
Role: PRINCIPAL_INVESTIGATOR
Centre Paul Strauss, Strasbourg
Locations
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Centre Paul Strauss
Strasbourg, , France
Zentralklinikum Augsburg
Augsburg, , Germany
Klinikum am Bruderwald, Sozialstiftung Bamberg
Bamberg, , Germany
Charité Campus Virchow Klinikum
Berlin, , Germany
Klinikum der Heinrich-Heine Universität
Düsseldorf, , Germany
J.W. Goethe-Universität
Frankfurt, , Germany
Martin-Luther Universität
Halle, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Klinikum Magdeburg gGmbH
Magdeburg, , Germany
Klinikum der Johannes-Gutenberg Universität
Mainz, , Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, , Germany
Universitätsklinikum der LMU Grosshadern
München, , Germany
Städtisches Klinikum Neuperlach
München, , Germany
Klinikum Oldenburg gGmbH
Oldenburg, , Germany
Klinikum der Universität Regensburg
Regensburg, , Germany
Countries
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Other Identifiers
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MT201-204
Identifier Type: -
Identifier Source: org_study_id