June 7, 2006

New Clinical Trial for Head and Neck Cancer Underway at SIU Med School

A new clinical trial to treat head and neck cancer in patients is underway at the SimmonsCooper Cancer Institute at SIU School of Medicine in Springfield. The Tarceva-RADPLAT trial is a phase II study being conducted only at SIU and will involve up to twenty patients. If the treatment is successful, it would expand to a multicenter trial and be studied at other cancer centers around the country.

"This trial is the first worldwide to test the potential benefits of combining a biologic agent with high dose intra-arterial chemotherapy and radiation therapy," said Dr. K. Thomas Robbins, director of SIU' s Cancer Institute and professor of otolaryngology head and neck surgery, who is co-directing the study.

The co-principal investigator for the trial is Dr. Krishna A. Rao, Ph.D., assistant professor of hematology and oncology and also a member of SIU's Cancer Institute.

"Tarceva is currently used to treat lung cancers," explained Rao. "This trial will give us the scientific evidence needed to see if the combination with intra-arterial chemoradiation may work with head and neck cancer and if any adjustments need to be made in the treatment protocol."

The treatment being studied combines radiation given five times a week and chemotherapy to treat stage III or IV cancer, known as squamous cell carcinoma, in a patient’s mouth, larynx or pharynx. The drugs being used are cisplatin, given once a week via a catheter placed in a patient’s artery, and Tarceva, taken once a day in a pill form.

Tarceva is approved by the FDA for treatment of lung and pancreatic cancer while this trial to study the treatment of head and neck cancer is considered investigational. The hope is that the drug will also prove as a safe treatment for head and neck cancer.

Individuals who are 18 and older are being sought. Patients will be treated for seven weeks, beginning with a two-day hospitalization. RADPLAT therapy or chemo-radiation therapy is billed to insurance in the usual manner. However, Tarceva is provided free of charge to participants by the study’s sponsor, Genentech, Inc., and OSI Pharmaceuticals.

With this treatment, like all chemotherapy and radiation, there can be common side effects, which may include sore mouth and loss of energy or weight. However, the majority of patients treated will have full recovery to pretreatment status. Standard treatment for advanced head and neck cancer involves either major surgery, with its high risk for loss of organ function, followed by radiation or intravenous chemoradiotherapy.

Robbins says the head and neck team at SIU has extensive experience with using the intra-arterial approach, which permits a much higher concentration of the drug to reach the tumor.

Patients can be referred to the SimmonsCooper Cancer Institute for evaluation and trial participation by their physician. Results will be shared with their personal physician.

For more information about the RADPLAT trial, call the clinical trials office at the SimmonsCooper Cancer Institute at SIU, 545-7929 weekdays.

There presently are 14 clinical trials underway for patients at the SimmonsCooper Cancer Institute at SIU, which is focusing the medical school’s efforts in cancer research, physician and public education, and treatment for patients from across central and southern Illinois. Its web site is www.siumed.edu/cancer .

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