Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer
A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer
2 other identifiers
interventional
150
12 countries
26
Brief Summary
In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety. The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2005
26 active sites
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
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 2, 2006
CompletedFirst Posted
Study publicly available on registry
February 3, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMay 1, 2012
April 1, 2012
February 2, 2006
April 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the percentage of patients surviving without disease progression in each arm at 9 months
Secondary Outcomes (4)
PFS rates at 3,6,12 months
Response rates
Overall survival (OS) in each arm
Safety
Study Arms (2)
FOLFOX 6
ACTIVE COMPARATORFOLFOX 6: * Oxaliplatin 100 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
FOLFIRI
ACTIVE COMPARATORFOLFIRI: * Irinotecan 180 mg/m² day 1 concurrent with * Leucovorin 400 mg/m² followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
Interventions
FOLFOX 6: * Oxaliplatin 100 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
FOLFIRI: * Irinotecan 180 mg/m² day 1 concurrent with * Leucovorin 400 mg/m² followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
Eligibility Criteria
You may qualify if:
- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic colorectal carcinoma not suitable for curative-intent resection
- Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment
- Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area)
- ECOG performance status of \< 2 at study entry
You may not qualify if:
- Brain metastasis (known or suspected)
- Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is \> 6 months
- Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry
- Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- Any investigational agent(s) within 4 weeks prior to entry
- Previous exposure to EGFR-pathway targeting therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
LKH Leoben, Abt. für Innere Medizin
Leoben, Styria, 8700, Austria
Univ. Klinik für Innere Medizin I
Vienna, 1090, Austria
Institute of Oncology
Sarajevo, 71000, Bosnia and Herzegovina
University Hospital "Queen Joanna"
Sofia, 1504, Bulgaria
SBALO National Oncology Center
Sofia, 1754, Bulgaria
University Hospital for Tumors
Zagreb, Croatia
University Hospital Rebro
Zagreb, Croatia
Bank of Cyprus Oncology Center
Nicosia, Cyprus
Univ. Hospital Brno, Dept. Of Clinical Oncology
Brno, 62500, Czechia
Charles University Prague, Dep. of Oncology
Prague, 12808, Czechia
National Medical Center
Budapest, 1135, Hungary
Markusovsy Hospital
Szomathely, 39700, Hungary
Csolnoky Ferenc County Hospital
Veszprém, 8200, Hungary
Hadassah Medical Center
Jerusalem, Israel
Souraski Medical Center
Tel Aviv, Israel
Hospital Amadora Sintra, Servico de Oncologia
Amadora, 2720, Portugal
Hospital de Beja
Beja, 78000, Portugal
Hospital Distrital de Faro
Faro, 8000-386, Portugal
Hospital Geral de Sto. António
Porto, 4000-377, Portugal
Hospital San Teotóno -
Viseu, Portugal
Institutul Oncologic Bucuresti
Bucharest, Romania
Institutul Oncologic Cluj
Cluj-Napoca, 400015, Romania
National Cancer Institute
Bratislava, 83310, Slovakia
Institute of Oncology
Ljubljana, 1000, Slovenia
Ankara Hacettepe University, Oncology Unit
Ankara, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, Turkey (Türkiye)
9 Eyul University Medical Faculty, Dep of Oncology
Izmir, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Werner Scheithauer, MD
Dep. of Internal Medicine I, Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2006
First Posted
February 3, 2006
Study Start
July 1, 2005
Study Completion
October 1, 2007
Last Updated
May 1, 2012
Record last verified: 2012-04