Overview

Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors

Status:
Unknown status
Trial end date:
2016-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Treatments:
Cetuximab
Everolimus
Sirolimus
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 alopecia)

- Appropriate organic functions as defined:

- ASAT and ALAT function due to the underlying disease

- Bilirubin
- Albumin >/= 3.0 g/dL

- Neutrophil counts (PNN) >/= 1 500/mL

- Platelets >/= 100 000/mL

- Hemoglobin >/= 9.0 g/dL

- Creatinin
- 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