Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases (MT201-204)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier:
NCT00866944
First received: March 20, 2009
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Liver Metastases
Colorectal Cancer
Drug: Adecatumumab
Drug: Adecatumumab and FOLFOX
Drug: FOLFOX 4
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen Research (Munich) GmbH:

Primary Outcome Measures:
  • Disease free survival rate (DFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Incidence of AEs [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: March 2009
Study Completion Date: November 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866944

Locations
France
Centre Paul Strauss
Strasbourg, France, 67065
Germany
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
Städtisches Klinikum Neuperlach
München, Germany, 81737
Universitätsklinikum der LMU Grosshadern
München, Germany, 81377
Klinikum Oldenburg gGmbH
Oldenburg, Germany, 26133
Klinikum der Universität Regensburg
Regensburg, Germany, 93053
Sponsors and Collaborators
Amgen Research (Munich) GmbH
Investigators
Principal Investigator: Peter Neuhaus, Prof. Dr. Charité Campus Virchow Klinikum, Berlin
Principal Investigator: Patrick Dufour, Pr. Dr. Centre Paul Strauss, Strasbourg
  More Information

No publications provided

Responsible Party: Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier: NCT00866944     History of Changes
Other Study ID Numbers: MT201-204
Study First Received: March 20, 2009
Last Updated: November 10, 2011
Health Authority: Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Liver Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014