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| ID | Type | Description | Link |
|---|---|---|---|
| 2010/1626 | Other Identifier | CSET number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab + Temsirolimus | Experimental | Cetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug |
| ||
| Temsirolimus |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Adverse effects will be assessed using NCI-CTC.AE v.4 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Tumorous response will be assessed using RECIST criteria | Assessed every 2 cycles (44 days) from inclusion up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy | Villejuif | Val de Marne | 94805 | France |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| C401859 | temsirolimus |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |