Temsirolimus and Irinotecan for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations (TIRASMUS)
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|ClinicalTrials.gov Identifier: NCT00827684|
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Irinotecan Drug: Temsirolimus||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Official Title:||Phase II Study of Temsirolimus and Irinotecan in Chemotherapy Refractory Patients With KRAS Mutated Metastatic Colorectal Cancer|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||June 2011|
Active Comparator: Response or stable disease
will receive Temsirolimus
Will receive a combination of Temsirolimus and Irinotecan
- Objective response rates
- Progression free survival
- Overall survival
- Translational Research
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): NCT00827684
|Rigshospitalet, Department of Oncology|
|Copenhagen, Denmark, DK-2100|
|Vejle Hospital, Dept. of Oncology|
|Study Chair:||Anders Jakobsen, MD, DMSc||Vejle Hospital|
|Principal Investigator:||Karen-Lise G Spindler, MD, PhD||Vejle Hospital|