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

Colorectal Cancer Clinical Trial

— MT201-204  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866944
• Other study ID #: MT201-204
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2009
• Last updated: November 10, 2011
• Start date: March 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Amgen Research (Munich) GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Adecatumumab
Adecatumumab,6-9mg/kg, every 14 days, 24 cycles
• Adecatumumab and FOLFOX
FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles
• FOLFOX 4
FOLFOX 4, every 14 days, 12 cycles

Locations

Country	Name	City	State
France	Centre Paul Strauss	Strasbourg
Germany	Zentralklinikum Augsburg	Augsburg
Germany	Klinikum am Bruderwald, Sozialstiftung Bamberg	Bamberg
Germany	Charité Campus Virchow Klinikum	Berlin
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 Magdeburg gGmbH	Magdeburg
Germany	Klinikum der Johannes-Gutenberg Universität	Mainz
Germany	Klinikum Mannheim GmbH Universitätsklinikum	Mannheim
Germany	Städtisches Klinikum Neuperlach	München
Germany	Universitätsklinikum der LMU Grosshadern	München
Germany	Klinikum Oldenburg gGmbH	Oldenburg
Germany	Klinikum der Universität Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Amgen Research (Munich) GmbH

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival rate (DFS)		1 year	No
Secondary	time to relapse		1 year	No
Secondary	Incidence of AEs		1 year	Yes
Secondary	Quality of Life		1 year	No