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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Squamous Cell Carcinoma

Keywords

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Carcinoma Head Neck

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Temsirolimus

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Shreveport, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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3066K1-147

Identifier Type: -

Identifier Source: org_study_id