Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 23 February 2016
• Main ID: NCT02215720
• Date of registration: 08/08/2014
• Prospective Registration: No
• Primary sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Public title: Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors TORERO
• Scientific title: Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors
• Date of first enrolment: April 2011
• Target sample size: 42
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02215720
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: SORIA Jean Charles, MD, PhD

• Name: Rudiger HASSELBERG

Key inclusion & exclusion 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 alopecia)

- Appropriate organic functions as defined:

- ASAT and ALAT function due to the underlying disease

- Bilirubin
- Albumin >/= 3.0 g/dL

- Neutrophil counts (PNN) >/= 1 500/mL

- Platelets >/= 100 000/mL

- Hemoglobin >/= 9.0 g/dL

- Creatinin
- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Patients With Advanced or Metastatic Solid Tumors

Intervention(s)

Drug: Cetuximab

Drug: Temsirolimus

Primary Outcome(s)

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]

Secondary Outcome(s)

Efficacy [Time Frame: Assessed every 2 cycles (44 days) from inclusion up to 24 months]

Secondary ID(s)

2010/1626

2010-012275-88

Source(s) of Monetary Support

Please refer to primary and secondary sponsors