Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors

NCT02215720 | Completed Phase 1

• 2 other identifiers: 2010-012275-882010/1626
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety

  Adverse effects will be assessed using NCI-CTC.AE v.4

  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 (1)

• Efficacy

  Assessed every 2 cycles (44 days) from inclusion up to 24 months

Study Arms (1)

Cetuximab + Temsirolimus

EXPERIMENTAL

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

Drug: Cetuximab; Drug: Temsirolimus

Interventions

Cetuximab DRUG

Cetuximab + Temsirolimus

Temsirolimus DRUG

Cetuximab + Temsirolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

MeSH Terms

Interventions

Cetuximab; temsirolimus

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 13, 2014
• Study Start: April 26, 2011
• Primary Completion: September 15, 2014
• Study Completion: May 4, 2016
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

FR (1)