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Clinical Trials/NCT01172769
NCT01172769CompletedPhase 2

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)

Hannover Medical School7 sites in 1 country42 target enrollmentStarted: June 1, 2010Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
42
Locations
7
Primary Endpoint
Progression free rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Temsirolimus

Experimental

Intervention: Temsirolimus (Biological)

Outcomes

Primary Outcomes

Progression free rate

Time Frame: 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 Outcomes

  • Time to disease progression(6 weeks (average))
  • Toxicity of temsirolimus(12 weeks)
  • Objective response rate(at week 12)
  • Overall survival(at week 12)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Viktor Grünwald

Associate Professor MD

Hannover Medical School

Study Sites (7)

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