Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases
NCT00866944 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2011-11-11
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.
Conditions
- Liver Metastases
- Colorectal Cancer
Interventions
- DRUG
-
Adecatumumab
Adecatumumab,6-9mg/kg, every 14 days, 24 cycles
- DRUG
-
Adecatumumab and FOLFOX
FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles
- DRUG
-
FOLFOX 4
FOLFOX 4, every 14 days, 12 cycles
Sponsors & Collaborators
-
Amgen Research (Munich) GmbH
lead INDUSTRY
Principal Investigators
-
Peter Neuhaus, Prof. Dr. · Charité Campus Virchow Klinikum, Berlin
-
Patrick Dufour, Pr. Dr. · Centre Paul Strauss, Strasbourg
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2011-07-31
- Completion
- 2011-11-30
Countries
- France
- Germany
Study Locations
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