Status:
COMPLETED
Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Central European Cooperative Oncology Group
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 +...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00286130
Start Date
July 1 2005
End Date
October 1 2007
Last Update
May 1 2012
Active Locations (27)
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1
LKH Leoben, Abt. für Innere Medizin
Leoben, Styria, Austria, 8700
2
Univ. Klinik für Innere Medizin I
Vienna, Austria, 1090
3
Institute of Oncology
Sarajevo, Bosnia and Herzegovina, 71000
4
University Hospital "Queen Joanna"
Sofia, Bulgaria, 1504