Patients With Advanced or Metastatic Solid TumorsPhase 1TORERONCT02215720
Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing Cetuximab and Temsirolimus in people with Patients With Advanced or Metastatic Solid Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Advanced or Metastatic Solid Tumors
- What is being tested?
- Cetuximab and Temsirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2011to 4 May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Temsirolimus and Cetuximab in Adults 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.
- Being tested
- Cetuximab, Temsirolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
TemsirolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab + Temsirolimus | Experimental | Cetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes Receives: Drug: Cetuximab; Drug: Temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse effects will be assessed using NCI-CTC.AE v.4
Measured: 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
Tumorous response will be assessed using RECIST criteria
Measured: Assessed every 2 cycles (44 days) from inclusion up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study start26 Apr 2011
- Primary completion15 Sep 2014
- Study completion4 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215720
- Sponsor's protocol ID
- 2010-012275-88
- Other IDs
- 2010/1626
- Acronym
- TORERO
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2014
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Hollebecque A, Bahleda R, Faivre L, Adam J, Poinsignon V, Paci A, Gomez-Roca C, Thery JC, Le Deley MC, Varga A, Gazzah A, Ileana E, Gharib M, Angevin E, Malekzadeh K, Massard C, Soria JC, Spano JP. Phase I study of temsirolimus in combination with cetuximab in patients with advanced solid tumours. Eur J Cancer. 2017 Aug;81:81-89. doi: 10.1016/j.ejca.2017.05.021. Epub 2017 Jun 12.
PubMed 28618305
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02215720
- Acronym / sponsor ID
- TORERO / 2010-012275-88
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 26 Apr 2011 (actual)
- Primary completion
- 15 Sep 2014 (actual)
- Study completion
- 4 May 2016 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab + Temsirolimus | Experimental | Drug: Cetuximab, Drug: TemsirolimusCetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab | Drug | Cetuximab + Temsirolimus |
| Temsirolimus | Drug | Cetuximab + Temsirolimus |
Primary outcome
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
1 secondary outcome
Efficacy
Time frame: Assessed every 2 cycles (44 days) from inclusion up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Results publication: PubMed 28618305Hollebecque A, Bahleda R, Faivre L, Adam J, Poinsignon V, Paci A, Gomez-Roca C, Thery JC, Le Deley MC, Varga A, Gazzah A, Ileana E, Gharib M, Angevin E, Malekzadeh K, Massard C, Soria JC, Spano JP. Phase I study of temsirolimus in combination with cetuximab in patients with advanced solid tumours. Eur J Cancer. 2017 Aug;81:81-89. doi: 10.1016/j.ejca.2017.05.021. Epub 2017 Jun 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cetuximab and Temsirolimus in people with Patients With Advanced or Metastatic Solid Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02215720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.