Colorectal Cancer Clinical Trial
Official title:
A Clinical Trial of the Safety and Efficacy of ABX-EGF in Combination With Irinotecan, Leucovorin, and 5-Fluorouracil in Subjects With Metastatic Colorectal Cancer
The purpose of this study is to determine if panitumumab, in combination with irinotecan, leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic colorectal cancer.
Indication Metastatic Colorectal Cancer Primary Objective To assess the safety of ABX-EGF in
combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (The
primary objective in the original protocol was to assess progression free survival after
treatment with ABX-EGF in combination with the Saltz regimen in subjects with metastatic
colorectal cancer).
Secondary Objective(s) To assess the clinical efficacy of ABX-EGF in combination with the
FOLFIRI regimen in subjects with metastatic colorectal cancer. (Secondary objectives in the
original protocol were to assess safety and additional measures of the clinical efficacy of
ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal
cancer).
To assess the pharmacokinetics (PK) of ABX-EGF in combination with the FOLFIRI regimen in
subjects with metastatic colorectal cancer. (Secondary objectives in the original protocol
were to assess the PK of ABX-EGF in combination with the Saltz regimen, and the PK of
irinotecan (IR) and its active metabolite SN-38 when IR is given in combination with
ABX-EGF, leucovorin (LV), and 5-fluorouracil (5-FU) in subjects with metastatic colorectal
cancer)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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