drugset / Trial / NCT01144195

A Clinical Trial of Panitumumab in Combination With FOLFIRI Chemotherapy as Second Line Treatment in Subjects With Metastatic Colorectal Cancer Expressing Wild-type KRAS and Who Had Progressed ≥ 6 Months After the Last Dose of the First Line Chemotherapy

NCT01144195 ↗

NaSingle-groupOpen-labelTreatment

Summary

First line chemotherapy treatment regimens for metastatic colorectal cancer (mCRC) present disease-free survival of more than 10 months, and as much as 12 and 15 months for many patients. It is evident that there are 2 groups of patients with metastatic colorectal cancer(mCRC): those who progress during first line treatment or in the 6 months following the last chemotherapy infusion and those who progress after this first 6-month period. There are currently no studies evaluating the efficacy of second line chemotherapy regimens according to the duration of response to first line treatment. It seems logical that patients with less aggressive tumours will benefit more from treatments targeting specific proteins, such as panitumumab, due to the shorter duration of these tumours cell cycle, which makes them less sensitive to chemotherapy. This study is therefore justified to determine an increase in activity and control of the disease in patients who progressed after 6 months of the last first line chemotherapy infusion for metastatic colorectal cancer(mCRC) in subjects expressing wild-type KRAS.

Timeline

Start
2009-09
Primary completion
2011-12
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Panitumumab Monoclonal antibody 6 mg/kg Intravenous

Indications