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

Sponsor

Amgen Research (Munich) GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT00866944

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Mar 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Disease free survival rate (DFS) [1 year]

Secondary Outcome Measures

time to relapse [1 year]
Incidence of AEs [1 year]
Quality of Life [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Centre Paul Strauss	Strasbourg	France	67065
2	Zentralklinikum Augsburg	Augsburg	Germany	86156
3	Klinikum am Bruderwald, Sozialstiftung Bamberg	Bamberg	Germany	96049
4	Charité Campus Virchow Klinikum	Berlin	Germany	13353
5	Klinikum der Heinrich-Heine Universität	Düsseldorf	Germany	40489
6	J.W. Goethe-Universität	Frankfurt	Germany	60590
7	Martin-Luther Universität	Halle	Germany	06120
8	Medizinische Hochschule Hannover	Hannover	Germany	30625
9	Universitätsklinikum Leipzig	Leipzig	Germany	04103
10	Klinikum Magdeburg gGmbH	Magdeburg	Germany	39130
11	Klinikum der Johannes-Gutenberg Universität	Mainz	Germany	55131
12	Klinikum Mannheim GmbH Universitätsklinikum	Mannheim	Germany	68167
13	Universitätsklinikum der LMU Grosshadern	München	Germany	81377
14	Städtisches Klinikum Neuperlach	München	Germany	81737
15	Klinikum Oldenburg gGmbH	Oldenburg	Germany	26133
16	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