Phase II trial of paclitaxel and granulocyte colony-stimulating factor-in patients with pancreatic carcinoma: A southwest oncology group study

Purpose: pancreatic cancer is difficult to treat, with most patients surgically unresectable at the time of diagnosis, Radiotherapy and chemotherapy can offer palliation, but more effective therapy is needed, This trial evaluated the effects of an aggressive schedule of paclitaxel given with granulocyte colony-stimulating factor (G-CSF) to patients with advanced pancreatic cancer, Patients and Methods: All patients were required to have a histologic diagnosis of pancreatic adenocarcinoma with measurable disease and no prior chemotherapy or radiation therapy, Patients had to have performance status of 0 to 2, pretreatment absolute granulocyte count greater than or equal to 1,500/mu L, and platelet count greeter than or equal to the institutional lower limit of normal, Following pretreat ment with dexamethasone, diphenhydramine, and cimetidine, patients received paclitaxel at a dose of 250 mg/m(2) by 24-hour infusion an day 1, repeated every 21 days. G-CSF was given at a dose of 5 mu g/kg/d on days 3 to 18 or until two consecutive absolute neutrophil counts (ANCs) greater than or equal to 10,000/mu L were obtained, Doses of paclitaxel were modified depending on nadir counts, Results: Forty-five patients were entered onto this study, with six ineligible, For the 39 eligible patients, there was one complete response (CR) and two partial responses (PRs), five stable/no responses, 23 increasing disease, two early deaths, and six patients whose assessment was inadequate to determine response, The response rate was therefore three of 39 or 8% (95% confidence interval [CI], 2% to 21%). The median survival time for the 39 eligible patients was 5 months, The most common toxicities were anemia, leukopenia/granulocytopenia, malaise/fatigue, nausea/vomiting, alopecia, thrombocytopenia, paresthesias, and liver function abnormalities, There was one death due to sepsis, Conclusion: Single-agent paclitaxel in this dose and schedule has minimal activity in pancreatic adenocarcinoma patients. (C) 1997 by American Society of Clinical Oncology.