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Therapeutic Areas: Oncology | Otolaryngology (Ear, Nose, Throat) | Family Medicine
Disease Category: Head and Neck Cancer
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

ECOG E1305 A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab In Patients with Recurrent Or Metastatic Head and Neck Cancer

Purpose

You are being asked to participate in this study because you have incurable head and neck cancer for which there is no curative therapy.

The purpose of this study is to compare the effects (good and bad) of the addition of a drug called bevacizumab to the standard chemotherapy to see which works better. We will determine if the combination of standard chemotherapy (cisplatin and docetaxel, cisplatin and 5-FU, carboplatin and docetaxel, or carboplatin and 5-FU) and bevacizumab can increase the effectiveness of treatment for head and neck cancer. This combination is experimental. We will determine if adding bevacizumab to standard therapy produces results that are better than those we would ordinarily expect. Currently, we do not know whether using bevacizumab will be effective. This is a subject of this study. Bevacizumab is approved by the Food and Drug Administration (FDA) for another type of cancer, colorectal cancer, but is not approved for head and neck cancer.

Bevacizumab is a monoclonal antibody (antibodies which are clones of a single parent cell) that is directed against a substance called vascular endothelial growth factor, or VEGF. VEGF helps blood vessels grow, and cancer cells produce too much of it. Bevacizumab stops the growth of blood vessels that feed the tumor. In other words, it can starve the tumor and prevent it from growing. Bevacizumab has been shown to enhance the effect of chemotherapy against cancer in some other cancer types.

Patient Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed Squamous Cell Cancer of the Head and Neck (SCCHN), from any primary site, including unknown primary cancers of the head and neck. Patient must not have nasopharyngeal carcinoma of histologic types WHO 2 or 3 or squamous cell carcinoma that originated in the skin.
  • Patients must have SCCHN that is either (a) recurrent, judged incurable by surgery or radiation or (b) metastatic.
  • NOTE: Patients who refuse radical resection for recurrent disease are eligible
  • NOTE: A second primary squamous cell carcinoma of the head and neck is allowed if eligibility is based on a recurrent or metastatic first primary squamous cell carcinoma of the head and neck.
  • Patients may have received one regimen of induction, concomitant chemoradiotherapy and/or adjuvant chemotherapy as part of initial potential curative therapy but must not have received prior chemotherapy for recurrent or metastatic disease.
  • A minimum of 4 months is required between last dose of chemotherapy or chemoradiotherapy and study treatment. In addition patients must be progression-free for at least 4 months after completion of chemotherapy or chemoradiotherapy or radiation plus cetuximab given with a curative intent. (Cetuximab therapy: 4 months is required between last dose of chemotherapy or chemoradiotherapy and study treatment if part of concurrent regimen, 8 weeks if part of adjuvant regimen post radiation).
  • Patients having progression after 2 cycles of induction chemotherapy are not eligible for the study.
  • No prior bevacizumab is allowed.

Patient Exclusion Criteria:

  • No prior chemotherapy or biologic/molecular targeted therapy for recurrent or metastatic SCCHN.
  • Patients having progression after 2 cycles of induction chemotherapy are not eligible for the study.

To Learn more
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

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Research Center Information: Sherman Health

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183110

Date Last Changed: July 17, 2013


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