Status:
COMPLETED
Efficacy Study of Temsirolimus to Treat Head and Neck Cancer
Lead Sponsor:
Hannover Medical School
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether temsirolimus is effective in the treatment of relapsed/recurrent squamous cell cancer of the head and neck (HNSCC)
Detailed Description
Temsirolimus is an inhibitor of the mammalian target of rapamycin (mTOR), a crucial regulator of cell cycle progression. It was approved in the treatment of advanced renal cell carcinoma. Temsirolimus...
Eligibility Criteria
Inclusion
- Signed written informed consent must be given prior to study inclusion
- Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)
- Measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after 1st line platinum-based chemotherapy
- Patients with loco-regional recurrence need to be progression free for at least 6 months after platinum-based radiochemotherapy, if locoregional recurrence is the only lesion
- Cetuximab must have been included in at least one prior line of therapy
- Disease is not amenable to surgery, radiotherapy or platinum-based chemotherapy
- At least one measurable lesion according to RECIST (Version 1.0) criteria
- Age \> 18 years
- ECOG performance status 0-2
- Brain metastases require completion of local therapy with discontinuation of steroids prior to start of treatment
- If of childbearing potential, willingness to use effective contraceptive method (double barrier method) for the study duration and 2 months after last dose
- Willingness and ability to comply with the protocol
- Adequate bone marrow function, liver and renal function
Exclusion
- Live expectancy less than 3 months
- Anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery
- Participation in a clinical trial within the last 30 days prior to study treatment
- Serious illness or medical condition other than the disease under study
- Other malignancies within 3 years, with exception of HNSCC, history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- Inability to potentially complete follow up and treatment per protocol for psychological, familial, sociological or geographical reasons
- Pregnancy or breast feeding
- Known allergic/hypersensitivity reaction to any component of the treatment
- Concurrent treatment with oral anticoagulants
- Uncontrolled diabetes: fasting serum glucose \> 2.0 ULN
- Active or uncontrolled infection
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01172769
Start Date
June 1 2010
End Date
March 1 2012
Last Update
November 8 2013
Active Locations (7)
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1
Charitè Berlin Campus Benjamin Franklin Medical Clinic III
Berlin, Germany, 12203
2
Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology
Duisburg, Germany, 47228
3
Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch)
Essen, Germany, 45147
4
Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV
Halle, Germany, 06120