Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations
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|ClinicalTrials.gov Identifier: NCT00792363|
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : June 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Irinotecan Drug: Panitumumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Irinotecan and Panitumumab as 3rd Line Treatment of Patients With Metastatic Colorectal Cancer Without KRAS Mutations|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||August 2011|
- Drug: Irinotecan
350 mg/m2 intravenously on day 1 every 3 weeks
- Drug: Panitumumab
9 mg/kg intravenously on day 1 every 3 weeks
- Response Rate [ Time Frame: Every 9 weeks. Up to 6 months ]
- Overall survival [ Time Frame: 6 months ]
- Progression free survival [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792363
|Vejle Hospital, Dept. of Oncology|
|Vejle, Denmark, DK-7100|
|Study Chair:||Anders Jakobsen, Professor||Vejle Hospital|