- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00286130
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
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC.
EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively.
Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Wien, Austria, 1090
- Univ. Klinik für Innere Medizin I
-
-
Steiermark
-
Leoben, Steiermark, Austria, 8700
- LKH Leoben, Abt. für Innere Medizin
-
-
-
-
-
Sarajevo, Bosnia and Herzegovina, 71000
- Institute of Oncology
-
-
-
-
-
Sofia, Bulgaria, 1754
- SBALO National Oncology Center
-
Sofia, Bulgaria, 1504
- University Hospital "Queen Joanna"
-
-
-
-
-
Zagreb, Croatia
- University Hospital Rebro
-
Zagreb, Croatia
- University Hospital For Tumors
-
-
-
-
-
Nikosia, Cyprus
- Bank of Cyprus Oncology Center
-
-
-
-
-
Brno, Czech Republic, 62500
- Univ. Hospital Brno, Dept. Of Clinical Oncology
-
Prague, Czech Republic, 12808
- Charles University Prague, Dep. of Oncology
-
-
-
-
-
Budapest, Hungary, 1135
- National Medical Center
-
Szomathely, Hungary, 39700
- Markusovsy Hospital
-
Veszprem, Hungary, 8200
- Csolnoky Ferenc County Hospital
-
-
-
-
-
Jerusalem, Israel
- Hadassah Medical Center
-
Tel Aviv, Israel
- Souraski Medical Center
-
-
-
-
-
Amadora, Portugal, 2720
- Hospital Amadora Sintra, Servico de Oncologia
-
Beja, Portugal, 78000
- Hospital de Beja
-
Faro, Portugal, 8000-386
- Hospital Distrital de Faro
-
Porto, Portugal, 4000-377
- Hospital Geral de Sto. António
-
Viseu, Portugal
- Hospital San Teotóno -
-
-
-
-
-
Bucuresti, Romania
- Institutul Oncologic Bucuresti
-
Cluj-Napoca, Romania, 400015
- Institutul Oncologic Cluj
-
-
-
-
-
Bratislava, Slovakia, 83310
- National Cancer Institute
-
-
-
-
-
Ljubljana, Slovenia, 1000
- Institute of Oncology
-
-
-
-
-
Ankara, Turkey
- Gazi University Medical Faculty
-
Ankara, Turkey
- Ankara Hacettepe University, Oncology Unit
-
Izmir, Turkey
- 9 Eyul University Medical Faculty, Dep of Oncology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: FOLFOX 6
FOLFOX 6:
|
FOLFOX 6:
|
Active Comparator: FOLFIRI
FOLFIRI:
|
FOLFIRI:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
the percentage of patients surviving without disease progression in each arm at 9 months
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety
|
Response rates
|
PFS rates at 3,6,12 months
|
Overall survival (OS) in each arm
|
Collaborators and Investigators
Investigators
- Principal Investigator: Werner Scheithauer, MD, Dep. of Internal Medicine I, Medical University of Vienna
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protective Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Micronutrients
- Vitamins
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Oxaliplatin
- Leucovorin
- Irinotecan
- Cetuximab
Other Study ID Numbers
- CECOG/Core 1.2.001
- EUDRACT number 2004-002391-42
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Colorectal Cancer
-
Mayo ClinicCompletedMetastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Metastatic... and other conditionsUnited States
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Active, not recruitingColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
Array Biopharma, now a wholly owned subsidiary...CompletedMetastatic Colorectal Cancer | Advanced Solid Tumors | Advanced or Metastatic Biliary CancerUnited States
-
Hutchison Medipharma LimitedActive, not recruitingMetastatic Colorectal Cancer | Metastatic Colon CancerUnited States, Spain, Japan, Australia, Austria, Belgium, Czechia, Estonia, France, Germany, Hungary, Italy, Poland, United Kingdom
-
Zhejiang Cancer HospitalNot yet recruitingMetastatic Colorectal Cancer | Metastatic Colorectal Adenocarcinoma | CRCChina
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingMetastatic Pancreatic Adenocarcinoma | Stage IV Pancreatic Cancer AJCC v6 and v7 | Stage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Metastatic Gastroesophageal Junction Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Malignant... and other conditionsUnited States
-
Dana-Farber Cancer InstituteAmerican Cancer Society, Inc.Not yet recruitingMetastatic Colorectal Cancer | Colorectal Cancer | Metastatic Colon CancerUnited States
-
AmgenCompletedCancer | Metastatic Colorectal Cancer | Colorectal Cancer | Rectal Cancer | Metastatic Cancer | Colon Cancer | Oncology
-
AmgenCompletedCancer | Metastatic Colorectal Cancer | Colorectal Cancer | Rectal Cancer | Metastatic Cancer | Colon Cancer
-
Symphogen A/STerminatedCarcinoma | Metastatic Colorectal Cancer | Colorectal Cancer MetastaticUnited States, Spain, Germany, Italy
Clinical Trials on Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
-
Gruppo Italiano per lo studio dei Carcinomi dell...CompletedMetastatic Colorectal CancerItaly
-
Seoul National University Bundang HospitalCompletedBiliary Cancer MetastaticKorea, Republic of
-
Novartis PharmaceuticalsActive, not recruitingMetastatic Colorectal CancerCanada, Taiwan, Belgium, Germany, Spain, Italy, Czechia, Switzerland, Australia, United States, Japan, Singapore, United Kingdom, France, Israel, Hong Kong, Korea, Republic of
-
PfizerCompletedColorectal NeoplasmsCanada, United States, France, Poland, Italy, Spain, Korea, Republic of, Japan
-
Zealand University HospitalRecruitingIntestinal Neoplasms | Colorectal Cancer | Rectal Cancer | Rectal Neoplasms | Colorectal Neoplasm | Chemotherapy Effect | Intestinal DiseaseDenmark
-
University of Wisconsin, MadisonBristol-Myers Squibb; Eli Lilly and Company; SanofiTerminatedRectal CancerUnited States
-
Hospital Alemão Oswaldo CruzRecruitingRectal Cancer | ConsolidationBrazil, Argentina, Uruguay
-
New Mexico Cancer Care AllianceCompletedPancreatic CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterTerminatedPancreatic CancerUnited States
-
Cliniques universitaires Saint-Luc- Université...Grand Hôpital de CharleroiTerminated