Phase I Clinical Trial of Concurrent Paclitaxel, Carboplatin, and External Beam Chest Irradiation with Glutamine in Patients with Locally Advanced Non-Small Cell Lung Cancer

Esophagitis is a dose-limiting toxicity of combined chemoradiation therapy in patients with locally advanced lung cancer. Our study aimed at minimizing this complication by using glutamine in an attempt to escalate the dose of chemotherapy. This was a Phase I trial of escalating the dose of weekly paclitaxel and carboplatin with concurrent radiation therapy. Fifteen patients were enrolled, with median age 62 years (58-78), 13 males and 12 Caucasians. Due to multiple severe toxicities including hematological toxicities and esophagitis, the combination was deemed not feasible. In conclusion, the addition of glutamine does not prevent serious toxities of this concurrent chemoradiotherapy regimen.