Status:
UNKNOWN
Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Patients With Advanced or Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02215720
Start Date
April 1 2011
End Date
October 1 2016
Last Update
February 10 2016
Active Locations (1)
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1
Gustave Roussy
Villejuif, Val de Marne, France, 94805