An Open-label Phase II Clinical Trial of Panitumumab in Combination With Irinotecan for Patients With Advanced Metastatic Colorectal Cancer Without KRAS Mutation (Wild Type) in Third Line Chemotherapy (Patients Pretreated With FOLFOX or XELOX ± Bevacizumab and Irinotecan Alone or FOLFIRI or CAPIRI ± Bevacizumab) [PIMABI]
- To assess the objective response rate when panitumumab is administered in combination
with irinotecan hydrochloride as third-line therapy in patients with advanced
metastatic colorectal cancer without KRAS mutation (wild type) previously treated with
FOLFOX or XELOX chemotherapy with or without bevacizumab and irinotecan hydrochloride
alone or FOLFIRI or CAPIRI chemotherapy with or without bevacizumab.
- To assess the efficacy in terms of disease control rate, duration of response, time to
response, progression-free survival, time to progression, time to treatment failure,
and duration of stable disease.
- To assess the efficacy and safety of this regimen, followed by panitumumab alone in
patients who discontinue third-line irinotecan hydrochloride due to toxicity.
- To correlate this regimen with EGFR expression, detection of the functional genetic
polymorphisms of the EGFR gene, EGFR gene amplification (FISH), EGFR activation
detection, EGFR downstream protein and gene expression parameters, proteomics, and
OUTLINE: This is a multicenter study.
Patients receive panitumumab IV over 30-90 minutes and irinotecan hydrochloride IV over 90
minutes on day 1. Patients who discontinue irinotecan hydrochloride may receive panitumumab
monotherapy. Courses repeat every 14 days in the absence of disease progression and
Archived tumor tissue specimens are obtained at baseline for correlative laboratory studies.
Tissue samples are analyzed for EGFR amplification status by chromogenic in situ
hybridization and fluorescence in situ hybridization, KRAS and KRAF mutations, and STAT3
After completion of study therapy, patients are followed at approximately 56 days.
Masking: Open Label, Primary Purpose: Treatment
Objective response rate (ORR; radiologically confirmed complete response [CR] or partial response [PR]) during the combination therapy phase
Thierry Andre, MD
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)