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Brief Title: Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC
Official Title: 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
Study ID: NCT00755534
Brief Summary: This phase II study will evaluate which is the best way to administer cetuximab after recurrence in 1st line irinotecan+bevacizumab based treatment and to obtain results of the efficacy of the oxaliplatin+cetuximab combination as 2nd line treatment.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital of Heraklion, Dep of Medical Oncology, Heraklion, Creta, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, , Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, , Greece
401 Military Hospital of Athens, Athens, , Greece
Air Forces Military Hospital of Athens, Athens, , Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, , Greece
State General Hospital of Larissa, Larissa, , Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology, Piraeus, , Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology, Thessaloniki, , Greece
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki, Thessaloniki, , Greece
Name: John Souglakos, MD
Affiliation: University Hospital of Crete
Role: PRINCIPAL_INVESTIGATOR