A phase II study of docetaxel-irinotecan combination in advanced pancreatic cancer.

Journal Article (Clinical Trial;Journal Article)

BACKGROUND/AIMS: Chemotherapy provides dismal results in advanced pancreatic cancer patients, even when new compounds, such as gemcitabine, are used. Phase I studies of single-drug therapy with docetaxel or irinotecan suggested a response rate of about 15% in these patients. We report here a phase II study of docetaxel-irinotecan combination in advanced pancreatic cancer patients. METHODOLOGY: Docetaxel 60 mg/m2 was given in combination with irinotecan 250 mg/m2 every 3 weeks. Prednisolone premedication and anti-HT3 drugs were systematically administered. Hematopoietic growth factors were given in case of febrile neutropenia or grade 4 neutropenia at the previous cycle. Endpoints were response rate, progression-free survival, and tolerance. RESULTS: Twenty-seven patients were enrolled, of whom 25 had metastatic disease. We observed 3 partial responses and 11 stabilizations. The median progression-free survival was 4.3 months. Myelosuppression was the main toxicity with 18% of patients experiencing a grade 3-4 event. One patient died of neglected febrile neutropenia. Gastrointestinal toxicity was well controlled. Other toxicities were mild. CONCLUSIONS: This combination has acceptable tolerance and, despite an 11% response rate, some partial responses and prolonged stabilizations were observed. The treatment induced clinical benefit in 33% of the patients. Further trials should focus on docetaxel or irinotecan, possibly used in combination with more conventional strategies (gemcitabine).

Full Text

Duke Authors

Cited Authors

  • Kurtz, J-E; Négrier, S; Husseini, F; Limacher, J-M; Borel, C; Wagner, J-P; Prévot, G; Bergerat, J-P; Dufour, P

Published Date

  • 2003

Published In

Volume / Issue

  • 50 / 50

Start / End Page

  • 567 - 570

PubMed ID

  • 12749274

International Standard Serial Number (ISSN)

  • 0172-6390


  • eng

Conference Location

  • Greece