Efficacy Study of Temsirolimus to Treat Head and Neck Cancer

Study Overview
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Brief Summary
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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
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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 demonstrated also antitumor activity in a variety of other human cancer models, such as gliomas, rhabdomyosarcomas, neuroblastomas, prostata and breast cancer through induction of apoptosis or inhibition of proliferation. A similar effect was noted in HNSCC cell lines. This is the first study evaluating the efficacy and safety of temsirolimus in platinum/cetuximab-refractory HNSCC.

Official Title
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A Single Arm, Open-label Multicenter Phase II Trial of Temsirolimus in Patients With Relapsed/Recurrent Squamous Cell Cancer of the Head and Neck (HNSCC)

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Biological: Temsirolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temsirolimus<br> | Biological: Temsirolimus<br>* After dissolving and dilution 25 mg of temsirolimus will be administered i.v. once a week by 30 minute infusion. Study treatment will continue until tumor progression or unless unacceptable toxicity is encountered.<br>* Other names: protein kinase inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free rate | The primary endpoint is the patients free of progression (PFR) at week 12 based on CT or MRI scans evaluated according to RECIST criteria. | at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression | time to disease progression | 6 weeks (average) | 
| Toxicity of temsirolimus | toxicity of temsirolimus are to be evaluated by CTC 3.0 criteria | 12 weeks | 
| Objective response rate | objective response rate by RECIST | at week 12 | 
| Overall survival | overall survival | at week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HNSCC