Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors (TORERO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02215720|
Recruitment Status : Unknown
Verified February 2016 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was: Recruiting
First Posted : August 13, 2014
Last Update Posted : February 10, 2016
Cetuximab is an EGFR inhibitor that has shown efficacy alone or in combination in colorectal cancer or head and neck cancer in several phase II/III studies.
Temsirolimus is a new mTOR inhibitor that has shown interesting results in several Phase I/II studies in advance kidney cancer of bad prognosis.
Study hypothesis is that combination of those two compounds and the inhibition of two pathways at the same time will have more efficiency on tumoral growth than the inhibition of those pathways in isolation.
|Condition or disease||Intervention/treatment||Phase|
|Patients With Advanced or Metastatic Solid Tumors||Drug: Cetuximab Drug: Temsirolimus||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||October 2016|
Experimental: Cetuximab + Temsirolimus
Cetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes
- Safety [ Time Frame: Assessed every every week from inclusion during the four first weeks then at week 8 then every 2 months until death or progression whichever comes first up to 24 months ]Adverse effects will be assessed using NCI-CTC.AE v.4
- Efficacy [ Time Frame: Assessed every 2 cycles (44 days) from inclusion up to 24 months ]Tumorous response will be assessed using RECIST criteria
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): NCT02215720
|Contact: SORIA Jean Charles, MD, PhD||0142114291 ext +email@example.com|
|Contact: HASSELBERG Rudiger, MD,PhD||0142116250 ext +firstname.lastname@example.org|
|Villejuif, Val de Marne, France, 94805|
|Contact: Rudiger HASSELBERG 0142116250 ext +33 email@example.com|
|Principal Investigator: Jean Charles SORIA, MD, PhD|