The Southwest Oncology Group (SWOG) is initiating a phase III trial (S0023) that will compare conventional chemoradiotherapy with consolidation docetaxel(Drug information on docetaxel) (Taxotere) followed by maintenance therapy with the investigational agent Iressa (ZD1839) vs placebo for the treatment of inoperable, locally advanced non-small-cell lung cancer.
Patient enrollment is under way, and approximately 840 men and women are being recruited. The National Cancer Institute is funding the trial.
"Recent studies have shown that Iressa shrinks tumors in patients with advanced non-small-cell lung cancer and is also associated with mild side effects," said study coordinator Karen Kelly, MD, associate professor of medicine at the University of Colorado Health Sciences Center in Denver.
Study Goals and Protocol
Standard treatment for this patient population is chemoradiotherapy, which in the past has produced a median survival rate of approximately 13 to 17 months and an approximate 3-year survival of 20%. "While, in the past, standard chemotherapy combinations with radiotherapy resulted in a small benefit on survival, there is a need for the development of novel cancer agents like Iressa that may improve therapeutic outcome," said Dr. Kelly.
The primary objectives of the trial are to determine whether treatment with ZD1839 improves overall and progression-free survival in patients with inoperable non-small-cell lung cancer who have been treated with chemotherapy and radiation and to assess the safety of its long-term use. An additional goal is to establish a lung cancer specimen bank that will store tissue from lung cancer patients for use in current and future scientific research studies.
Participants in the trial will be randomized to receive one of two treatment regimens: cisplatin(Drug information on cisplatin) (Platinol), etoposide(Drug information on etoposide), and radiation followed by docetaxel and ZD1839; or cisplatin, etoposide, and radiation followed by docetaxel and placebo. Treatment will continue in each arm for a maximum of 5 years.