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