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

Completed

Conditions studied: Squamous Cell Carcinoma

In brief

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 standard therapy for their specific disease. The primary objective of this study is to identify biomarkers of temsirolimus activity.

Key facts

Study ID

NCT00195299

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

20

Starts

2005-04-01

Expected to finish

2007-02-01

Last updated by the study team

2007-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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