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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Liver Metastases
• Intervention / Treatment: Drug: Adecatumumab; Drug: Adecatumumab and FOLFOX; Drug: FOLFOX 4

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67065
    • Centre Paul Strauss
• Germany
  • Augsburg, Germany, 86156
    • Zentralklinikum Augsburg
  • Bamberg, Germany, 96049
    • Klinikum am Bruderwald, Sozialstiftung Bamberg
  • Berlin, Germany, 13353
    • Charite Campus Virchow Klinikum
  • Düsseldorf, Germany, 40489
    • Klinikum der Heinrich-Heine Universität
  • Frankfurt, Germany, 60590
    • J.W. Goethe-Universität
  • Halle, Germany, 06120
    • Martin-Luther Universität
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig
  • Magdeburg, Germany, 39130
    • Klinikum Magdeburg gGmbH
  • Mainz, Germany, 55131
    • Klinikum der Johannes-Gutenberg Universität
  • Mannheim, Germany, 68167
    • Klinikum Mannheim GmbH Universitätsklinikum
  • München, Germany, 81377
    • Universitätsklinikum der LMU Grosshadern
  • München, Germany, 81737
    • Städtisches Klinikum Neuperlach
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg gGmbH
  • Regensburg, Germany, 93053
    • Klinikum der Universität Regensburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Adecatumumab alone	Drug: Adecatumumab; Adecatumumab,6-9mg/kg, every 14 days, 24 cycles; Other Names: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: March 20, 2009
• First Submitted That Met QC Criteria: March 20, 2009
• First Posted (Estimate): March 23, 2009

Study Record Updates

• Last Update Posted (Estimate): November 11, 2011
• Last Update Submitted That Met QC Criteria: November 10, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Colorectal carcinoma; R0 resection; Liver metastases (only); R0 resection of liver metastases from colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Liver Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms; Neoplasms, Second Primary; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Fluorouracil; Oxaliplatin; Leucovorin; Antibodies, Monoclonal
• Other Study ID Numbers: MT201-204