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NCT00195299 Clinical Trial

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

Squamous Cell Carcinoma Clinical Trial

Official title:
An Exploratory Biomarker Trail of Temsirolimus in Subjects With Newly Diagnosed Advanced Stage Squamous Cell Carcinoma of the Head & Neck

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00195299
Other study ID # 3066K1-147
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated December 18, 2007
Start date April 2005
Est. completion date February 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Temsirolimus

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

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