Efficacy Study of Temsirolimus to Treat Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Biological: Temsirolimus

• Registration Number: NCT01172769
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-07-30
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Temsirolimus	Temsirolimus	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to disease progression	6 weeks (average)	time to disease progression
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
Overall survival	at week 12	overall survival

Trial Locations

Locations (7)

Charitè Berlin Campus Benjamin Franklin Medical Clinic III; 🇩🇪 Berlin, Germany

Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV; 🇩🇪 Halle, Germany

Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology; 🇩🇪 Duisburg, Germany

Universitätsklinikum Jena Clinic for Ear, Nose and Throat; 🇩🇪 Jena, Germany

Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch); 🇩🇪 Essen, Germany

Medical School Hannover Clinic for Heamatology, Hemostaseology, Oncology and stem cell transplantation; 🇩🇪 Hannover, Germany

Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat; 🇩🇪 Leipzig, Germany