Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations
The purpose of this study is to investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without KRAS mutations.
Metastatic Colorectal Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Irinotecan and Panitumumab as 3rd Line Treatment of Patients With Metastatic Colorectal Cancer Without KRAS Mutations|
- Response Rate [ Time Frame: Every 9 weeks. Up to 6 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Study Completion Date:||August 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Colorectal cancer is one of the most frequent types of cancer in Denmark with approximately 3,400 diagnosed patients per year. The prognosis for these patients is still very poor and more than half of them will develop metastatic disease and thus be candidates for chemotherapy.
In Denmark 5-FU and Oxaliplatin or Irinotecan has been used for several years either as combination or mono therapy. In recent years biological antibodies targeted against EGFR have been added to this treatment. A newly developed antibody is Panitumumab, which enables treatment every 3 weeks instead of weekly administration.
The effect of EGFR activation is mediated through intracellular pathways involving the KRAS protein. It has been proven that a mutation of KRAS causes the KRAS protein to be constantly activated, and patients with these mutations do not benefit from antibodies against EGFR. Approximately 40% of the patients present these mutations.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792363
|Vejle Hospital, Dept. of Oncology|
|Vejle, Denmark, DK-7100|
|Study Chair:||Anders Jakobsen, Professor||Vejle Hospital|