Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors (TORERO)

Gustave Roussy

Status and phase: Unknown; Phase 1

Conditions: Patients With Advanced or Metastatic Solid Tumors

Treatments: Drug: Temsirolimus; Drug: Cetuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT02215720

2010-012275-88

2010/1626 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Cetuximab + Temsirolimus

Experimental group

Description:

Cetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes

Treatment:

Drug: Temsirolimus

Drug: Cetuximab