Colorectal Carcinoma Clinical Trial
The first phase II trial with cetuximab and FOLFOX, as 1st line therapy for MCRC, presented
at ASCO 2004, showed a 81% response rate, with no unexpected toxicities for the combination.
This study is aimed at establishing the efficacy and safety of the combination
cetuximab/XELOX as first line therapy in patients with MCRC.
The phase II trials with XELOX, demonstrated that is a highly effective first-line treatment
for metastatic colorectal cancer, with response rates similar to the regimens with
oxaliplatin and infusional 5-FU/LV (FOLFOX), but more convenient and likely to be preferred
by both patients and health care providers.
Cetuximab has a significant anti-cancer activity in the setting of chemo-resistant disease
which suggests that a much greater degree of benefit may ensue when it is used at an earlier
stage of the disease course.
The first phase II trial with cetuximab and FOLFOX, as 1st line therapy for MCRC, presented
at ASCO 2004, showed a 81% response rate, with no unexpected toxicities for the combination.
This study is aimed at establishing the efficacy and safety of the combination
cetuximab/XELOX as first line therapy in patients with MCRC.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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