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)
18 Years
N/A
Both
Head and Neck Squamous Cell Carcinoma
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free rate
Outcome Description:
The primary endpoint is the patients free of progression (PFR) at week 12 based on CT or MRI scans evaluated according to RECIST criteria.
Outcome Time Frame:
at week 12
Safety Issue:
No
Principal Investigator
Viktor Gruenwald, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical School Hannover
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
HN001
NCT ID:
NCT01172769
Start Date:
June 2010
Completion Date:
February 2014
Related Keywords:
- Head and Neck Squamous Cell Carcinoma
- HNSCC
- Carcinoma
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
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