NCT00866944

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2009

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 11, 2011

Status Verified

November 1, 2011

Enrollment Period

2.3 years

First QC Date

March 20, 2009

Last Update Submit

November 10, 2011

Conditions

Liver MetastasesColorectal Cancer

Keywords

Colorectal carcinomaLiver metastases (only)R0 resectionR0 resection of liver metastases from colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Disease free survival rate (DFS)

    1 year

Secondary Outcomes (3)

  • time to relapse

    1 year

  • Incidence of AEs

    1 year

  • Quality of Life

    1 year

Study Arms (3)

1

EXPERIMENTAL

Adecatumumab alone

Drug: Adecatumumab

2

EXPERIMENTAL

FOLFOX 4 followed by Adecatumumab

Drug: Adecatumumab and FOLFOX

3

ACTIVE COMPARATOR

FOLFOX 4 alone

Drug: FOLFOX 4

Interventions

AdecatumumabDRUG

Adecatumumab,6-9mg/kg, every 14 days, 24 cycles

Also known as: MT201
1
Adecatumumab and FOLFOXDRUG

FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles

2
FOLFOX 4DRUG

FOLFOX 4, every 14 days, 12 cycles

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Centre Paul Strauss

Strasbourg, 67065, France

Location

Zentralklinikum Augsburg

Augsburg, 86156, Germany

Location

Klinikum am Bruderwald, Sozialstiftung Bamberg

Bamberg, 96049, Germany

Location

Charité Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Klinikum der Heinrich-Heine Universität

Düsseldorf, 40489, Germany

Location

J.W. Goethe-Universität

Frankfurt, 60590, Germany

Location

Martin-Luther Universität

Halle, 06120, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Klinikum Magdeburg gGmbH

Magdeburg, 39130, Germany

Location

Klinikum der Johannes-Gutenberg Universität

Mainz, 55131, Germany

Location

Klinikum Mannheim GmbH Universitätsklinikum

Mannheim, 68167, Germany

Location

Universitätsklinikum der LMU Grosshadern

München, 81377, Germany

Location

Städtisches Klinikum Neuperlach

München, 81737, Germany

Location

Klinikum Oldenburg gGmbH

Oldenburg, 26133, Germany

Location

Klinikum der Universität Regensburg

Regensburg, 93053, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

adecatumumabFolfox protocol

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Peter Neuhaus, Prof. Dr.

    Charité Campus Virchow Klinikum, Berlin

    PRINCIPAL INVESTIGATOR

  • Patrick Dufour, Pr. Dr.

    Centre Paul Strauss, Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2009

First Posted

March 23, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2011

Study Completion

November 1, 2011

Last Updated

November 11, 2011

Record last verified: 2011-11

Locations

DE(15)FR(1)