Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases

Phase 2

Completed

• Conditions: Liver Metastases; Colorectal Cancer
• Interventions: Drug: Adecatumumab and FOLFOX; Drug: FOLFOX 4; Drug: Adecatumumab

• Registration Number: NCT00866944
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-23
• Primary Completion: 2011-07
• Status Verified: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-10
• Last Update Posted: 2011-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Adecatumumab and FOLFOX	FOLFOX 4 followed by Adecatumumab
3	FOLFOX 4	FOLFOX 4 alone
1	Adecatumumab	Adecatumumab alone

Primary Outcome Measures

Name	Time	Method
Disease free survival rate (DFS)	1 year

Secondary Outcome Measures

Name	Time	Method
time to relapse	1 year
Incidence of AEs	1 year
Quality of Life	1 year

Trial Locations

Locations (16)

Klinikum der Johannes-Gutenberg Universität; 🇩🇪 Mainz, Germany

Klinikum Mannheim GmbH Universitätsklinikum; 🇩🇪 Mannheim, Germany

Universitätsklinikum der LMU Grosshadern; 🇩🇪 München, Germany

Städtisches Klinikum Neuperlach; 🇩🇪 München, Germany

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Charité Campus Virchow Klinikum; 🇩🇪 Berlin, Germany

Zentralklinikum Augsburg; 🇩🇪 Augsburg, Germany

Klinikum am Bruderwald, Sozialstiftung Bamberg; 🇩🇪 Bamberg, Germany

Klinikum der Heinrich-Heine Universität; 🇩🇪 Düsseldorf, Germany

J.W. Goethe-Universität; 🇩🇪 Frankfurt, Germany

Martin-Luther Universität; 🇩🇪 Halle, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Klinikum Oldenburg gGmbH; 🇩🇪 Oldenburg, Germany

Klinikum Magdeburg gGmbH; 🇩🇪 Magdeburg, Germany

Klinikum der Universität Regensburg; 🇩🇪 Regensburg, Germany