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

Abstract

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).

• Authors: Jean-Emmanuel Kurtz, Sylvie Négrier, Fares Husseini, Jean-Marc Limacher, Christian Borel, Jean-Philippe Wagner, Gilles Prévot, Jean-Pierre Bergerat, Patrick Dufour
• Journal: Hepato-gastroenterology (Hepatogastroenterology) 2003 Mar-Apr Vol. 50 Issue 50 Pg. 567-70 ISSN: 0172-6390 [Print] Greece
• PMID: 12749274 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Antineoplastic Agents, Phytogenic
• Taxoids
• Docetaxel
• Irinotecan
• Paclitaxel
• Camptothecin

Topics

• Adenocarcinoma (drug therapy, mortality, pathology)
• Aged
• Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Bone Marrow (drug effects)
• Camptothecin (administration & dosage, adverse effects, analogs & derivatives)
• Diarrhea (chemically induced)
• Docetaxel
• Humans
• Irinotecan
• Liver Neoplasms (secondary)
• Middle Aged
• Paclitaxel (administration & dosage, adverse effects, analogs & derivatives)
• Pancreatic Neoplasms (drug therapy, mortality, pathology)
• Taxoids