Phase II Study of Avastin Plus Erbitux Plus Irinotecan as 2nd Line Treatment of Locally Advanced or Metastatic Colorectal Cancer in Patients Achieving Disease Progression as Best Response After 1st Line Treatment With FOLFIRI+Avastin or XELIRI+Avastin
Treating patients with primary resistance to the most active multi-agent combination remains
a challenging clinical problem. The reported data demonstrated that addition of ERBITUX may
reverse IRINOTECAN resistance. Further data support the feasibility of the combination of
two monoclonal antibodies (AVASTIN+ERBITUX) with IRINOTECAN with better responses compared
to historical controls (ERBITUX±IRINOTECAN). As such, a phase II study was designed to
evaluate the efficacy of the combination of AVASTIN plus ERBITUX plus IRINOTECAN as second
line treatment in patients progressing while on treatment with FOLFIRI AVASTIN or XELIRI
AVASTIN
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time To Progression
1 year
No
John Souglakos, MD
Principal Investigator
University Hospital of Crete
Greece: National Organization of Medicines
CT/05.32
NCT00681876
April 2008
February 2010
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