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lüll Phase II trial of oral rubitecan in previously treated pancreatic cancer patients Burris HA 3rd; Rivkin S; Reynolds R; Harris J; Wax A; Gerstein H; Mettinger KL; Staddon AOncologist 2005[Mar]; 10 (3): 183-90BACKGROUND: Additional systemic treatments for locally advanced or metastatic pancreatic cancer are needed, as current treatment options produce only modest survival benefits. Rubitecan (Orathecin; Supergen Inc., Dublin, CA, http://www.supergen.com) is an orally active camptothecin derivative with demonstrated responses in patients with pancreatic cancer in early clinical trials. This phase II, open-label trial was developed to assess the safety and efficacy of rubitecan in patients with locally advanced or metastatic pancreatic cancer refractory to conventional chemotherapy. METHODS: Fifty-eight patients with failed or relapsed advanced pancreatic cancer after receiving at least one prior chemotherapy regimen were enrolled to receive eight consecutive weeks of treatment with rubitecan at a dose of 1.5 mg/m2 orally on five consecutive days per week, followed by 2 days off therapy, repeatedly. The primary end point was response rate. Time to progression, overall survival, changes in CA19-9 levels, and the composite measure of clinical benefit response were evaluated as secondary end points. RESULTS: Among 43 patients with measurable disease, 7% (3/43) achieved partial responses and 16% (7/43) had disease stabilization for an overall response and disease stabilization rate of 23%. All responses were confirmed by independent radiology review. Median survival was longer in responding patients than in the overall study cohort (10 months versus 3 months). Gastrointestinal and hematologic toxicities were the most commonly reported adverse events. CONCLUSION: Oral rubitecan produced responses and was well tolerated by heavily pretreated patients with refractory pancreatic cancer. The overall risk-benefit profile of oral rubitecan appears promising, supporting further evaluation in phase III trials in patients with refractory and chemotherapy-naive pancreatic cancer.|Administration, Oral[MESH]|Adult[MESH]|Aged[MESH]|Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use[MESH]|Camptothecin/administration & dosage/adverse effects/*analogs & derivatives/*therapeutic use[MESH]|Disease Progression[MESH]|Female[MESH]|Humans[MESH]|Male[MESH]|Middle Aged[MESH]|Pancreatic Neoplasms/*drug therapy/pathology[MESH]|Survival Analysis[MESH] |