Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors
NCT ID: NCT02215720
Last Updated: 2016-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
42 participants
INTERVENTIONAL
2011-04-30
2016-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cetuximab + Temsirolimus
Cetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes
Cetuximab
Temsirolimus
Interventions
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Cetuximab
Temsirolimus
Eligibility Criteria
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Inclusion Criteria
* Age \>/= 18 years
* ECOG 0 or 1
* Life expectancy \>/= 12 weeks
* Grade \</=1 for all adverse effects related to previous therapy or surgery (except for alopecia)
* Appropriate organic functions as defined:
* ASAT and ALAT \</= 2.5xLSN or ASAT and ALAT \</= 5xLSN in case of inappropriate hepatic function due to the underlying disease
* Bilirubin \</= 1.5xLSN
* Albumin \>/= 3.0 g/dL
* Neutrophil counts (PNN) \>/= 1 500/mL
* Platelets \>/= 100 000/mL
* Hemoglobin \>/= 9.0 g/dL
* Creatinin \</= 1.5xLSN
* Cooperative patients able to respect the protocol
Exclusion Criteria
* Previous treatment with an association of mTOR inhibitor or EGFR inhibitor
* Diagnosis of a secondary cancer within the last 3 years except for a basal-cell carcinoma, cutaneous spinocellular cancer or in situ carcinoma well treated
* Grade \>/= 2 nephropathy according to NCI CTCAE
* Current treatment with curative dose of coumadin or heparin of low molecular weight
* Previous uncontrolled brain metastases, medullar compression or carcinomatosis meningitis or any proof of leptomeningeal pathology or metastasis.
* Presence of one og those pathologies during the last 12 months before the inclusion:
* myocardial infarction
* angina pectoris
* bypass of coronal or peripheral arteries
* heart failure
* stroke
* cerebral bleeding
* pulmonary embolism
* Grade 3 bleeding according to NCI CTCAE criteria less than 3 weeks before treatment start
* Uncontrolled high blood pressure (\>150/100mhHg)
* Grade \>/=2 heart rate disorder, atrial fibrillation whichever the grade, lengthen of QTC \>450 msec for male or \>470 msec for female.
* Patients HIV positive
* Pregnant or breastfeeding woman
* Patients with psychiatric disorder
* Active alcoholism
* Previous pulmonary interstitial disease
* Previous hypersensitivity to antihistamine treatment and/or medical contraindication for an antihistamine or corticoid treatment
18 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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Gustave Roussy
Villejuif, Val de Marne, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2010/1626
Identifier Type: OTHER
Identifier Source: secondary_id
2010-012275-88
Identifier Type: -
Identifier Source: org_study_id
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