PHASE-II TRIAL OF EDATREXATE IN SMALL-CELL LUNG-CANCER

Background. Long-term survival with extensive stage small cell lung ca ncer is rare. There have been no major advances in the treatment of th is stage of disease in the last 15-20 years. New agents with activity against this malignancy are needed. This study was designed to evaluat e the efficacy of edatrexate against small cell lung cancer in a Phase II trial. Methods. This was a multicenter cooperative oncology group trial. Patients were either previously untreated or had failed only on e prior chemotherapy regimen. All previously untreated patients had ex tensive stage disease. Patients in whom prior therapy had been unsucce ssful had either limited or extensive stage disease. All cases had his tologic documentation. Patients received edatrexate (80 mg/m(2)) intra venously over 20-30 minutes every 7 days. Previously untreated patient s with disease progression at any time or stable disease after 6 weeks of treatment were crossed over to treatment with cisplatin and etopos ide. The primary end points of the study were clinical response and to xicity to edatrexate. All patients were observed for survival. Results . Eleven previously untreated and 22 previously treated patients were enrolled. A median of five doses of chemotherapy was given to each gro up. No major clinical response was observed in either group. The media n survival time for the 11 previously untreated patients was 9.8 month s versus 3.7 months for individuals who had received prior therapy. My elosuppression and stomatitis were the primary toxicities, and both we re infrequent. Conclusions. Edatrexate is inactive against small cell lung cancer.