drugset / Trial / NCT01068132

Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab.

NCT01068132 ↗

NaSingle-groupOpen-labelTreatment

Summary

Italian, multicentre, non comparative trial in patients with advanced Colorectal Cancer(CRC)and KRAS wild-type, defined by molecular evaluation. Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity developed or patient refusal. The aim of this study is to assess the prognostic role of PTEN in terms of Progression free survival. Although the role of Cetuximab as first line treatment in metastatic CRC will be soon established, it is still unclear which is the best schedule for Cetuximab and the role of biological factors in order to select the most appropriate subset of pts for recommending Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the perspective to study the role of other molecular markers in this subset of pts. On the basis of these considerations this study is aimed at testing a different schedule of Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate.

Timeline

Start
2009-04
Primary completion
2013-10
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 500 mg/m2 —
Background FU Unknown 400 mg/m2 Intravenous
Background FU Unknown 600 mg/m2 Intravenous
Background Irinotecan Small molecule 180 mg/m2 —
Background LV Unknown 100 mg/m2 —

Indications