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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195299
First received: September 12, 2005
Last updated: December 18, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention
Squamous Cell Carcinoma
Drug: Temsirolimus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Exploratory Biomarker Trail of Temsirolimus in Subjects With Newly Diagnosed Advanced Stage Squamous Cell Carcinoma of the Head & Neck

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Estimated Enrollment: 20
Study Start Date: April 2005
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195299

Locations
United States, Louisiana
Shreveport, Louisiana, United States, 71130
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00195299     History of Changes
Other Study ID Numbers: 3066K1-147
Study First Received: September 12, 2005
Last Updated: December 18, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Carcinoma
Head
Neck

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 23, 2014