Clinical trial NCT02215720: Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors
Official title: Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Patients With Advanced or Metastatic Solid Tumors
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 \</=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:

* Treatment by chemotherapy, radiotherapy, surgery or the two compounds of the study within 4 weeks before the inclusion
* 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

Primary outcomes:
measure: Safety
timeFrame: 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
Secondary outcomes:
measure: Efficacy
timeFrame: Assessed every 2 cycles (44 days) from inclusion up to 24 months
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val de Marne
Study officials:
References: