Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer
NCT ID: NCT00286130
Last Updated: 2012-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2005-07-31
2007-10-31
Brief Summary
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The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FOLFOX 6
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:
Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
FOLFOX 6
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
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
Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
FOLFIRI
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
Interventions
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Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
FOLFOX 6
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
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
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Central European Cooperative Oncology Group
OTHER
Responsible Party
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Principal Investigators
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Werner Scheithauer, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Internal Medicine I, Medical University of Vienna
Locations
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LKH Leoben, Abt. für Innere Medizin
Leoben, Styria, Austria
Univ. Klinik für Innere Medizin I
Vienna, , Austria
Institute of Oncology
Sarajevo, , Bosnia and Herzegovina
University Hospital "Queen Joanna"
Sofia, , Bulgaria
SBALO National Oncology Center
Sofia, , 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, , Czechia
Charles University Prague, Dep. of Oncology
Prague, , Czechia
National Medical Center
Budapest, , Hungary
Markusovsy Hospital
Szomathely, , Hungary
Csolnoky Ferenc County Hospital
Veszprém, , Hungary
Hadassah Medical Center
Jerusalem, , Israel
Souraski Medical Center
Tel Aviv, , Israel
Hospital Amadora Sintra, Servico de Oncologia
Amadora, , Portugal
Hospital de Beja
Beja, , Portugal
Hospital Distrital de Faro
Faro, , Portugal
Hospital Geral de Sto. António
Porto, , Portugal
Hospital San Teotóno -
Viseu, , Portugal
Institutul Oncologic Bucuresti
Bucharest, , Romania
Institutul Oncologic Cluj
Cluj-Napoca, , Romania
National Cancer Institute
Bratislava, , Slovakia
Institute of Oncology
Ljubljana, , 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)
Countries
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Other Identifiers
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EUDRACT number 2004-002391-42
Identifier Type: -
Identifier Source: secondary_id
CECOG/Core 1.2.001
Identifier Type: -
Identifier Source: org_study_id
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