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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215720
Recruitment Status : Unknown
Verified February 2016 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : August 13, 2014
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE August 8, 2014
First Posted Date  ICMJE August 13, 2014
Last Update Posted Date February 10, 2016
Study Start Date  ICMJE April 2011
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
Efficacy [ Time Frame: Assessed every 2 cycles (44 days) from inclusion up to 24 months ]
Tumorous response will be assessed using RECIST criteria
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors
Official Title  ICMJE Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Patients With Advanced or Metastatic Solid Tumors
Intervention  ICMJE
  • Drug: Cetuximab
  • Drug: Temsirolimus
Study Arms  ICMJE Experimental: Cetuximab + Temsirolimus
Cetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes
Interventions:
  • Drug: Cetuximab
  • Drug: Temsirolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 12, 2014)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02215720
Other Study ID Numbers  ICMJE 2010-012275-88
2010/1626 ( Other Identifier: CSET number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP