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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

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
Patients With Advanced or Metastatic Solid Tumors Drug: Cetuximab Drug: Temsirolimus Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2011
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cetuximab + Temsirolimus
Cetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes
Drug: Cetuximab
Drug: Temsirolimus



Primary Outcome Measures :
  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 Outcome Measures :
  1. Efficacy [ Time Frame: Assessed every 2 cycles (44 days) from inclusion up to 24 months ]
    Tumorous response will be assessed using RECIST criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215720


Contacts
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Contact: SORIA Jean Charles, MD, PhD 0142114291 ext +33 jean-charles.soria@gustaveroussy.fr
Contact: HASSELBERG Rudiger, MD,PhD 0142116250 ext +33 rudgier.hasselberg@gustaveroussy.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Rudiger HASSELBERG    0142116250 ext +33    rudiger.hasselberg@gustaveroussy.fr   
Principal Investigator: Jean Charles SORIA, MD, PhD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT02215720    
Other Study ID Numbers: 2010-012275-88
2010/1626 ( Other Identifier: CSET number )
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Neoplasms
Sirolimus
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs