A Parallel Phase II Study With Irinotecan/Cetuximab (Until PD) Followed by XELOX/Cetuximab (Until PD) vs the Reverse Sequence in Metastatic CRC With Previous Benefit on Irinotecan/Bevacizumab Based Therapy
Because of the recent advances in the field of systemic chemotherapy for mCRC, like
irinotecan, oxaliplatin, capecitabine, and targeted agents (Cetuximab, Bevacizumab) mCRC
patients have an overall survival that in some cases reaches 25 months.Irinotecan is an
inhibitor of the DNA enzyme topoisomerase I, with use in clinical practice for the last 10
years.In a phase II study with mCRC patients resistant to irinotecan based therapy the
combination of irinotecan and Cetuximab (an IgG1 anti-EGFR antibody) yielded a response rate
of 22.5%.Capecitabine was shown to have improved tolerability and response rate compared
with bolus 5-FU, with comparable time to progression and survival.Oxaliplatin has been
approved by the FDA for 2nd line treatment in the metastatic CRC setting as a number of
trials have shown promising data for response rates, disease stabilization rates,median
progression free survival (PFS) and overall survival (OS).KRAS is a predictive marker for
clinical benefit from EGFR-based antibody treatment. KRAS is the first molecular marker for
selection of a targeted therapy in combination with a standard chemotherapy regimen.
Patients with KRAS wild-type tumors have a strong benefit from the administration of
cetuximab with better PFS and objective responses.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time To Progression
1 year
No
John Souglakos, MD
Principal Investigator
University Hospital of Crete
Greece: National Organization of Medicines
CT/05.31
NCT00755534
November 2008
November 2008
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