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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)

Phase 2
18 Years
Open (Enrolling)
Head and Neck Squamous Cell Carcinoma

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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

- 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:


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:


Principal Investigator

Viktor Gruenwald, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical School Hannover


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

June 2010

Completion Date:

February 2014

Related Keywords:

  • Head and Neck Squamous Cell Carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms