Efficacy Study of Temsirolimus to Treat Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma Clinical Trial

— TEMHEAD  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172769
• Other study ID #: HN001
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2010
• Last updated: November 7, 2013
• Start date: June 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2013
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Biological:
• Temsirolimus
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.

Locations

Country	Name	City	State
Germany	Charitè Berlin Campus Benjamin Franklin Medical Clinic III	Berlin
Germany	Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology	Duisburg
Germany	Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch)	Essen
Germany	Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV	Halle
Germany	Medical School Hannover Clinic for Heamatology, Hemostaseology, Oncology and stem cell transplantation	Hannover
Germany	Universitätsklinikum Jena Clinic for Ear, Nose and Throat	Jena
Germany	Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to disease progression	time to disease progression	6 weeks (average)	No
Secondary	Toxicity of temsirolimus	toxicity of temsirolimus are to be evaluated by CTC 3.0 criteria	12 weeks	Yes
Secondary	Objective response rate	objective response rate by RECIST	at week 12	No
Secondary	Overall survival	overall survival	at week 12	No