PHASE-II STUDY OF CARBOPLATIN AND EDATREXATE (10-EDAM) WITH LEUCOVORIN RESCUE FOR PATIENTS WITH RECURRENT SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK

Recurrent squamous cell carcinoma of the head and neck is poorly respo nsive to chemotherapy in most patients; therefore, the development of new approaches is essential. Edatrexate is a new antifolate with impro ved preclinical antitumor activity when compared to methotrexate. The purpose of this study was to define the feasibility and efficacy of co mbining edatrexate with another active single agent, carboplatin in ch emotherapy-naive recurrent disease. Carboplatin was given as an outpat ient on day 1 at a dosage based on the formula: Dose (mg/m(2)) = (0.09 1) (creatinine clearance) (body surface area) (desired percentage chan ge in platelet count) + 86. Edatrexate (80 mg/m(2)) was given on days 1, 8, and 15 of a 21 day cycle. Calcium leucovorin 15 mg was given ora lly every 6 h for 4 doses after edatrexate. Of the 26 patients entered on the study, 1 was inevaluable for toxicity or response and 3 patien ts were evaluable for toxicity only. Grade 3 or 4 neutropenia occurred in 2 patients each, and grade 3 or 4 thrombocytopenia occurred in 2 a nd 4 patients, respectively. Grade 3 stomatitis occurred in only two p atients. Overall, major responses occurred in 2 of 22 evaluable patien ts (9%). The combination of carboplatin and edatrexate was not superio r to the results expected with either agent alone.