PHASE-II TRIAL OF URACIL TEGAFUR (UFT) PLUS LEUCOVORIN IN PATIENTS WITH ADVANCED PANCREATIC-CARCINOMA - A UNIVERSITY-OF-CHICAGO PHASE-II CONSORTIUM STUDY/

Background/objectives: Uracil and tegafur in a 4:1 molar concentration ratio (UFT; Bristol-Myers Squibb,Wallingford, CT) has broad anti-tumo r activity for cancers arising from the gastrointestinal tract. Howeve r, there are no published data regarding the efficacy of leucovorin-mo dulated UFT in patients with pancreatic cancer. The objective of this trial was to determine the activity and evaluate the toxicity of UFT p lus oral calcium leucovorin in patients with advanced pancreatic adeno carcinoma. Patients and methods: Fourteen patients with advanced measu rable adenocarcinoma of the pancreas were enrolled onto the trial. Pat ients received 300 mg/m(2)/d UFT plus 90 mg/d leucovorin administered orally in divided doses every eight hours for 28 days repeated every 3 5 days. Objective tumor response was evaluated after two courses of th erapy. Results. Fourteen patients were evaluable for response and toxi city. No objective responses were seen. The median (range) time to pro gression and survival were 14 (1.6-37), and 15 (1.9-62) weeks, respect ively. Toxicity was mild with severe (grade 3 or 4) hyperbilirubinemia , pain, diarrhea, transaminitis, venous thrombus, weakness, renal fail ure, confusion, and edema/ascites seen in three (21%), one (7%), two ( 14%), one (7%), one (7%), one (7%), one (7%), one (7%), and two (14%) patients. respectively. Conclusion: In the 14 patients evaluable, UFT 300 mg/m(2)/d plus oral leucovorin 90 mg/d administered for 28 days di d not demonstrate anti-tumor activity against advanced pancreatic aden ocarcinoma; however, this oral regimen was well tolerated and devoid o f neutropenia, significant oral mucositis or diarrhea.