E1305: A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab In Patients With Recurrent Or Metastatic Head and Neck Cancer

Study Status

Open to Enrollment

Study Description

Click Here to View the Study Flyer.pdf

The purpose of this study is to see how well standard chemotherapy works with the addition of a drug called bevacizumab in treating patients with recurrent or metastatic head and neck cancer.

Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Bevacizumab is a monoclonal antibody that stops the growth of blood vessels that feed a tumor. In other words, it can starve the tumor and prevent it from growing. Bevacizumab may also make tumor cells more sensitive to chemotherapy.

Bevacizumab is approved by the FDA for for colorectal cancer, but it is not approved for head and neck cancer. The combination of bevacizumab with standard chemotherapy is experimental. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab in treating head and neck cancer.

Patients will be randomly assigned to one of two study arms:

  • Arm 1: Patients receive chemotherapy comprising docetaxel and cisplatin OR cisplatin and fluorouracil
  • Arm 2: (Experimental) Patients receive chemotherapy as in Arm 1 plus bevacizumab

Patients will be in the study for several months, until they no longer respond to treatment. After 6 cycles (18 weeks) of chemotherapy, the study physician will determine if a patient would benefit from additional cycles of chemotherapy. We would like to keep track of patients' medical condition for 5 years to look at the long-term effects of the study.

Key Eligibility

  • Men and women age 18 and older
  • Squamous cell cancer of the head and neck
  • Recurrent or metastatic disease
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Elizabeta Popa, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (212) 746-9498
roh2026@med.cornell.edu

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