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Combination Therapy for Head and Neck Cancer

Name of the Trial

Phase I Study of Bortezomib and Radiotherapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (NCI-01-C-0104H). See the protocol summary.


Dr. Barbara A. Conley, principal investigator, NCI's Center for Cancer Research; Dr. Carter Van Waes, co-investigator, National Institute on Deafness and Other Communication Disorders; and Dr. David Gius, co-investigator, NCI's Radiation Oncology Branch

Why This Trial Is Important

Head and neck cancers account for three percent of all cancers in the United States. Most of these cancers begin in squamous cells found in the lining of structures in the head and neck. Initial treatment options for most patients with head and neck cancer include surgery followed by radiation therapy or chemotherapy combined with radiation treatment. No standard therapy currently exists for head or neck cancer that recurs after treatment with radiation.

In the past, doctors have been reluctant to re-treat patients with radiation if their cancer recurred. However, some studies of "re-irradiation" have shown long-term survival rates of up to 20 percent. This study is the first test of whether the drug bortezomib (Velcade) can increase the effectiveness of re-irradiation. Bortezomib, a proteasome inhibitor, is one of the new class of targeted cancer therapies. Proteasomes are clusters of proteins necessary for cancer cell growth.

"In preclinical studies conducted in the laboratories of Drs. Carter Van Waes and James Mitchell at NIH, bortezomib has been shown to inhibit growth of head and neck cancer cells, inhibit their blood supply, and enhance the effect of radiation," said Dr. Conley. "In this study we hope to see a similar effect in patients."

Another goal of this phase I study is to identify the most tolerable dose of bortezomib that can be given with radiation to the head and neck.

For More Information

This study has been completed. To find other clinical trials for head and neck cancers, search the NCI's listing of clinical trials or call the NCI Clinical Trial Referral Office at 1-888-NCI-1937. The call is toll free and confidential.

Published Results

Lebowitz PF, Harkins C, Conley B, et al.: Concomitant therapy with proteasome inhibitor, bortezomib, and radiation in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2010, 499, 2003.

Van Waes C, Chang AA, Lebowitz PF, et al: Inhibition of nuclear factor-κB and target genes during combined therapy with proteasome inhibitor bortezomib and reirradiation in patients with recurrent head-and-neck squamous cell carcinoma. Int J Radiation Oncology Biol Phys 63 (5) 1400–1412, 2005. [PUBMED Abstract]

  • Posted: March 23, 2004
  • Updated: October 14, 2010