Status:

COMPLETED

Study Evaluating Temsirolimus in Advanced Stage Squamous Cell Carcinoma of the Head & Neck

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Squamous Cell Carcinoma

Eligibility:

All Genders

18+ years

Brief Summary

This is an open-label, exploratory, biomarker study of intravenous temsirolimus given once weekly for 3 weeks to newly diagnosed, advanced stage head and neck cancer subjects prior to beginning their ...

Eligibility Criteria

Inclusion

  • Subjects with newly diagnosed, advanced stage, head and neck squamous cell carcinoma of the oral cavity, oral pharynx, hypopharynx or larynx.
  • Subjects willing to undergo tumor biopsies.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  • Age \>/= 18 years.

Exclusion

  • Subjects receiving anticoagulation therapy.
  • Presence of unstable angina, recent myocardial infarction (within the previous 6 months), or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia.
  • Prior cancer therapy (chemotherapy, hormonal therapy, radiotherapy, immunotherapy) or investigational agent for their head and neck cancer.

Key Trial Info

Start Date :

April 1 2005

Trial Type :

OBSERVATIONAL

End Date :

February 1 2007

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00195299

Start Date

April 1 2005

End Date

February 1 2007

Last Update

December 27 2007

Active Locations (1)

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1

Shreveport, Louisiana, United States, 71130