Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer

This study is currently recruiting participants.

Verified by Thomas Jefferson University, April 2007

First Received: November 29, 2006 Last Updated: April 23, 2007 History of Changes

Sponsors and Collaborators:	Thomas Jefferson University Genentech
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00405405

Purpose

To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer

Condition	Intervention	Phase
Head and Neck Cancer. Parotid Gland, Thyroid Gland and Melanoma Cases Stage IV Head and Neck Caner	Drug: Erlotinib and bevacizumab	Phase I

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Erlotinib Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

The primary endpoint of this study is toxicity, specifically the rate of Dose Limiting toxicity (DLT).

Estimated Enrollment:	27
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2010

Detailed Description:

Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although recent data suggest a benefit from induction therapy as well. Nonetheless, despite high remission rates, most of these patients will suffer local-regional and/or distant recurrence from their disease. The proposed study will build upon the framework of chemoradiotherapy (induction plus concurrent) via the addition of a double biologic therapy.

Specifically, the combination of bevacizumab and erlotinib will be used, as has been studied in other types of cancer.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Locally advanced Carcinoma (epithelial malignancy) of the head and neck. This may include non-squamous carcinomas (e.g. parotid, thyroid, melanoma) in which a large portion of mucosa of the oral cavity and/or laryngopharynx is expected to be irradiated.
Stage IV disease (T4Nany or TanyN2-3).

Exclusion Criteria:

Current, recent (within 4 weeks of the Day 1, the first infusion of drug in this study) or planned participation in an experimental drug study other than this one.
Poorly controlled blood pressure, defined as systolic bp > 150 and/or diastolic bp > 100 despite medication.
Unstable angina.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405405

Contacts

Contact: Jorosali Lavarino, BS	215-955-8619	jorosali.lavarino@jeffersonhospital.org
Contact: Joanne Ciconte, BS	215-955-8619	joanne.ciconte@jeffersonhospital.org

Locations

United States, Pennsylvania
Thomas Jefferson University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Mitchell Machtay, MD 215-955-6706 mitchell.machtay@jeffersonhospital.org
Contact: Rita Axelrod, MD 215-955-8874 rita.axelrod@jefferson.edu

Sponsors and Collaborators

Thomas Jefferson University

Genentech

Investigators

Principal Investigator:

Mitchell Machtay, MD

Thomas Jefferson University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	06C.46
Study First Received:	November 29, 2006
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00405405 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:

Head and neck cancers

Study placed in the following topic categories:

Erlotinib
Head and Neck Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Head and Neck Neoplasms

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009