PHASE-II TRIAL OF TOPOTECAN AS A 21-DAY CONTINUOUS-INFUSION IN PATIENTS WITH ADVANCED OR METASTATIC ADENOCARCINOMA OF THE PANCREAS

The aim of this study was to determine the efficacy and toxicity of to potecan administered as a 21-day continuous intravenous infusion in pa tients with advanced or metastatic adenocarcinoma of the pancreas. 26 previously untreated patients with advanced or metastatic pancreatic a denocarcinoma received topotecan at a dose of 0.5 mg/m(2)/day or 0.6 m g/m(2)/day as a continuous intravenous infusion for 21 days. Courses w ere repeated every 28 days. 26 patients were assessable for response a nd toxicity on an intent-to-treat basis. The initial 8 patients at a s tarting dose of 0.6 mg/m(2)/day experienced unacceptable myelosuppress ion and dose delays. The subsequent 18 patients, therefore began thera py at a dose of 0.5 mg/m(2)/day. The major toxicity of topotecan at th is dose and schedule was myelosuppression, which was reversible and no n-cumulative. There were no complete responses and two partial respons es for a total response rate of 8% (95% confidence interval, 1-25%). R esponse durations were 17 and 45 weeks. Stable disease was seen in 3 p atients. The median time to progression for all patients was 8 weeks a nd the median survival was 20 weeks. Topotecan given as a 21-day conti nuous intravenous infusion has a similar response rate and median surv ival to our previously reported study of the 5-day short infusion regi men in pancreatic carcinoma. (C) 1998 Elsevier Science Ltd. All rights reserved.