UT Southwestern initiates lung-cancer clinical trial
DALLAS - Sept. 15, 2004 - UT Southwestern Medical Center is recruiting patients with non-small cell lung cancer for a clinical trial that uses an experimental drug taken orally combined with radiation therapy.
"This is an exciting clinical trial, and we are the only site in the world currently participating," said Dr. Hak Choy, chairman of radiation oncology and principal investigator for the trial. "We're optimistic this therapy will be safe and beneficial in certain lung cancer patients."
Lung cancer is the leading cause of cancer death in the United States, and the overall five-year survival rate of patients is 15 percent. Most forms of the disease can be categorized into "small cell" and "non-small cell," which are divided into these two categories because of their size and their different reactions to treatments. Non-small cell, the most common form, is slower growing but less likely to respond to chemotherapy than the small-cell form.
Research in lung-cancer treatment has led to a growing interest in the use of combined therapies, such as radiation and chemotherapy. In the UT Southwestern clinical trial, the experimental drug satraplatin will be administered orally in conjunction with radiotherapy five times a week for seven weeks, said Dr. Choy. In subsequent groups of patients, the drug dosage will be increased. Satraplatin has shown promising results in earlier clinical trials against prostate, ovarian and lung tumors, and it is readily absorbed when taken by mouth.
Researchers are hopeful that satraplatin will be a better alternative to the Food and Drug Administration-approved platinum-based drug cisplatin, currently used to treat lung cancer. It has been shown to increase radiation-induced damage to tumors, but must be administered intravenously and can result in serious side effects.
About 30 patients are needed for the first phase of the clinical trial, which is expected to last 12 to 18 months and is designed to find the right treatment dose and assess toxicity. Participants must not have received prior chemotherapy or radiotherapy.
The second phase will determine if satraplatin combined with radiotherapy is effective overall and further evaluate the drug's safety. Another group of 30 patients will be recruited for this phase, which will last two years.
All patients will be followed for at least six weeks after the last dose of satraplatin and radiation therapy or until recovery from all toxic effects, whichever is longer.
For more information on enrolling in the clinical trial for non-small cell lung cancer, contact the W.A. Monty & Tex Moncrief Radiation Oncology facility at UT Southwestern at 214-648-5536.