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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris (Other)
Overall Status
Unknown status
CT.gov ID
NCT02215720
Collaborator
(none)
42
Enrollment
1
Location
1
Arm
66
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors
Study Start Date :
Apr 1, 2011
Anticipated Primary Completion Date :
Oct 1, 2016
Anticipated Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cetuximab + Temsirolimus

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

Drug: Cetuximab

Drug: Temsirolimus

Outcome Measures

Primary Outcome Measures

  1. Safety [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 Outcome Measures

  1. Efficacy [Assessed every 2 cycles (44 days) from inclusion up to 24 months]

    Tumorous response will be assessed using RECIST criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gustave Roussy Villejuif Val de Marne France 94805

Sponsors and Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT02215720
Other Study ID Numbers:
  • 2010-012275-88
  • 2010/1626
First Posted:
Aug 13, 2014
Last Update Posted:
Feb 10, 2016
Last Verified:
Feb 1, 2016
Additional relevant MeSH terms:
Neoplasms
Sirolimus
Cetuximab

Study Results

No Results Posted as of Feb 10, 2016