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OpenTrials
Completed

NCT Number: NCT02215720

Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors

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.

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Key information

Conditions

Patients With Advanced or Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetuximab

Drug

temsirolimus

Drug

Primary outcomes

  1. Safety

    Time frame: 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

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

Secondary outcomes

  1. Efficacy

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

    Tumorous response will be assessed using RECIST criteria

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors

Acronym: TORERO

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Aug 13, 2014
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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