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Completed
NCT02215720
Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors
Conditions: Patients With Advanced or Metastatic Solid Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 45
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Location: Gustave Roussy Villejuif Val de Marne
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Patients with malignant tumor confirmed histologically or cytologically who does not respond to usual therapeutics or for whom there is no curative treatment
* Age \>/= 18 years
* ECOG 0 or 1
* Life expectancy \>/= 12 weeks
* Grade \/= 9.0 g/dL
* Creatinin \/= 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
Source: ClinicalTrials.gov (NCT02215720). StuddyBuddy aggregates publicly available trial information.