Trial record 1 of 1 for:    MT201
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Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases (MT201-204)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00866944
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : November 11, 2011
Information provided by (Responsible Party):
Amgen Research (Munich) GmbH

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.

Condition or disease Intervention/treatment Phase
Liver Metastases Colorectal Cancer Drug: Adecatumumab Drug: Adecatumumab and FOLFOX Drug: FOLFOX 4 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Experimental: 1
Adecatumumab alone
Drug: Adecatumumab
Adecatumumab,6-9mg/kg, every 14 days, 24 cycles
Other Name: MT201

Experimental: 2
FOLFOX 4 followed by Adecatumumab
Drug: Adecatumumab and FOLFOX
FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles

Active Comparator: 3
FOLFOX 4 alone
Drug: FOLFOX 4
FOLFOX 4, every 14 days, 12 cycles

Primary Outcome Measures :
  1. Disease free survival rate (DFS) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. time to relapse [ Time Frame: 1 year ]
  2. Incidence of AEs [ Time Frame: 1 year ]
  3. Quality of Life [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00866944

Centre Paul Strauss
Strasbourg, France, 67065
Zentralklinikum Augsburg
Augsburg, Germany, 86156
Klinikum am Bruderwald, Sozialstiftung Bamberg
Bamberg, Germany, 96049
Charité Campus Virchow Klinikum
Berlin, Germany, 13353
Klinikum der Heinrich-Heine Universität
Düsseldorf, Germany, 40489
J.W. Goethe-Universität
Frankfurt, Germany, 60590
Martin-Luther Universität
Halle, Germany, 06120
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Klinikum Magdeburg gGmbH
Magdeburg, Germany, 39130
Klinikum der Johannes-Gutenberg Universität
Mainz, Germany, 55131
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, Germany, 68167
Universitätsklinikum der LMU Grosshadern
München, Germany, 81377
Städtisches Klinikum Neuperlach
München, Germany, 81737
Klinikum Oldenburg gGmbH
Oldenburg, Germany, 26133
Klinikum der Universität Regensburg
Regensburg, Germany, 93053
Sponsors and Collaborators
Amgen Research (Munich) GmbH
Principal Investigator: Peter Neuhaus, Prof. Dr. Charité Campus Virchow Klinikum, Berlin
Principal Investigator: Patrick Dufour, Pr. Dr. Centre Paul Strauss, Strasbourg

Responsible Party: Amgen Research (Munich) GmbH Identifier: NCT00866944     History of Changes
Other Study ID Numbers: MT201-204
First Posted: March 23, 2009    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: November 2011

Keywords provided by Amgen Research (Munich) GmbH:
Colorectal carcinoma
Liver metastases (only)
R0 resection
R0 resection of liver metastases from colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Antibodies, Monoclonal
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents