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Name of the Trial

Phase III Randomized Study of Palifermin for Reducing Oral Mucositis in Patients with Locally Advanced Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx Undergoing Concurrent Radiotherapy and Chemotherapy (RTOG-0435). See the protocol summary ³.

Principal Investigator

Dr. David I. Rosenthal Principal Investigator

Dr. David I. Rosenthal, Radiation Therapy Oncology Group.

Why This Trial Is Important

Nonsurgical treatment of locally advanced head and neck cancer usually involves a combination of radiotherapy and chemotherapy (chemoradiotherapy). Unfortunately, both the disease and its treatment are associated with serious oral complications. A common side effect of chemoradiotherapy is oral mucositis, inflammation of the mucous membranes in the mouth and throat that can cause painful sores. Severe oral mucositis can lead to delays in treatment, difficulty in eating and speaking, and life-threatening infections.

Palifermin has been approved by the FDA to prevent and treat mucositis in patients undergoing high-dose chemotherapy and radiotherapy for leukemia or lymphoma. It promotes the growth of mucosal cells lining the mouth and gastrointestinal tract and helps replace cells damaged by cancer treatment.

In this trial, patients undergoing chemoradiotherapy for advanced head and neck cancer will receive intravenous palifermin or placebo before and during cancer treatment.

"Chemoradiotherapy for head and neck cancer has led to significant improvements in survival, but those improvements have come at the cost of greater incidence of oropharyngeal mucositis, the most common reason for unplanned treatment interruptions," said Dr. Rosenthal. "Based on preclinical data and its proven efficacy in leukemia and lymphoma, palifermin is the most promising agent for reducing the burden of mucositis for head and neck cancer patients."

Contact Information

This trial is no longer accepting patients. To locate other clinical trials for head and neck cancer, search the NCI database of clinical trials ⁴ or call the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and confidential.

Glossary Terms

Treatment with drugs that kill cancer cells.

The stomach and intestines. The gastrointestinal tract is part of the digestive system, which also includes the salivary glands, mouth, esophagus, liver, pancreas, gallbladder, and rectum.

Cancer that arises in the head or neck region (in the nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx [voice box]).

The moist, inner lining of some organs and body cavities (such as the nose, mouth, lungs, and stomach). Glands in the mucous membrane make mucus (a thick, slippery fluid). Also called mucosa.

A form of keratinocyte growth factor (KGF) that is made in the laboratory. KGF stimulates the growth of cells that line the surface of the mouth and intestinal tract. Palifermin is used to prevent and treat oral mucositis (mouth sores) caused by high-dose chemotherapy and radiation therapy in leukemia and lymphoma. It is also being studied in the prevention and treatment of oral mucositis and dysphagia (difficulty swallowing) in other types of cancer. Palifermin is a type of recombinant human keratinocyte growth factor. Also called Kepivance.

An inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiotherapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiation therapy.