Metastatic Colorectal Cancer Clinical Trial
Official title:
Phase II Study of Temsirolimus and Irinotecan in Chemotherapy Refractory Patients With KRAS Mutated Metastatic Colorectal Cancer
The purpose of this study is to investigate the safety and efficacy of temsirolimus as a single drug, and of temsirolimus in combination with irinotecan in chemotherapy resistant patients with KRAS mutated colorectal cancer.
Chemotherapy resistance is a major challenge in metastatic colorectal cancer (mCRC), and
EGFR inhibitors have been introduced as 3rd line treatment to chemotherapy refractory
patients. However, it has recently been established that response to treatment with
irinotecan and cetuximab is confined to patients with wtKRAS tumors. Therefore, downstream
targets are being proposed as potential inhibitors of the EGFR signalling in tumours with
KRAS mutations. mTOR is a central intracellular signalling molecule and a rational approach
for potential reversion of chemotherapy resistance in these patients.
Preclinical data suggest that different solid tumors could respond to mTOR inhibitors and
report on enhanced antitumor activity in combination with different traditional cytostatic
drugs. Furthermore recent preclinical data suggest that mTOR inhibition may induce tumor
reduction in colon cancer xenographs. Temsirolimus (CCI-779) has been widely investigated in
different clinical settings and is presently registered for treatment of renal cell
carcinomas. Furthermore, is has recently shown response in metastatic breast cancer
patients, but at present there are no clinical data on efficacy or safety in metastatic
colorectal cancer patients.
The present study aims at investigating the safety and efficacy of monotherapy temsirolimus
and a combination of temsirolimus and irinotecan in chemotherapy resistant, KRAS mutated
colorectal adenocarcinomas.
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Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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