Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
HNSCC
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 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.
Interventions
BIOLOGICALTemsirolimus
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.
Sponsors
Hannover Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free rate | at week 12 | The primary endpoint is the patients free of progression (PFR) at week 12 based on CT or MRI scans evaluated according to RECIST criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity of temsirolimus | 12 weeks | toxicity of temsirolimus are to be evaluated by CTC 3.0 criteria |
| Objective response rate | at week 12 | objective response rate by RECIST |
| Time to disease progression | 6 weeks (average) | time to disease progression |
| Overall survival | at week 12 | overall survival |
Countries
Germany
Outcome results
None listed