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


N/A
18 Years
N/A
Not Enrolling
Both
Squamous Cell Carcinoma

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3066K1-147

NCT ID:

NCT00195299

Start Date:

April 2005

Completion Date:

February 2007

Related Keywords:

  • Squamous Cell Carcinoma
  • Carcinoma
  • Head
  • Neck
  • Carcinoma
  • Carcinoma, Squamous Cell

Name

Location

Metairie, Louisiana  70006