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Phase II trial of CPT-11 in patients with advanced pancreatic cancer, an EORTC early clinical trials group study |
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| Authors: | Wagener, D. J. Th. Verdonk, H. E. R. Dirix, L. Y. Catimel, G. Siegenthaler, P. Buitenhuis, M. Mathieu-Boue, A. Verweij, J. |
| Affiliation: | 1Department of Medical Oncology, University Hospital Nijmegen 2NDDO, Free University Hospital Amsterdam, The Netherlands 3University Hospital Antwerp Edegem, Belgium 4Department of Medical Oncology, Centre Leon Berard Lyon, France 5Hopital des Cadolles Neuchatel, Switzerland 6Bellon Rhone-Poulenc Rorer, Neuilly sur Seine France 7Department of Medical Oncology, Rotterdam Cancer Institute Rotterdam, The Netherlands |
| Abstract: | BACKGROUND: CPT-11 (irinotecan) is a semi-synthetic derivative of camptothecinand exerts its activity by inhibiting DNA topoisomerase I. Aphase II study of this drug was performed in patients with pancreaticcancer. PATIENTS AND METHODS: Eligibility criteria included advanced non-chemotherapy-pretreatedpancreatic cancer. CPT-11 was administered as a 30-minute i.v.infusion at a dose of 350 mg/m2 diluted in 250 ml normal salineevery 3 weeks. RESULTS: Thirty-four eligible patients were enrolled in the study, thirty-twoof them were evaluated, and three achieved partial responses(9%; 95% C.I. = 3%25%). The duration of response was7.2, 7.5 and 7.8 months, respectively. Thirteen patients hadno change, fourteen patients had progressive disease and twohad early progressive disease. The median duration of survivalfor all patients treated was 5.2 months. The main toxicities(CTC grade>3) were diarrhea, leuko-cytopenia, asthenia, nauseaand vomiting in, respectively, 7%, 16%, 8%, 6%, 4% of the courses.Thse toxicities were reversible and manageable with anti-emeticsand prophylactic or curative antidiarrheal agents. CONCLUSION: CPT-11 is an interesting moderately effective drug in pancreaticcancer. CPT-11, irinotecan, pancreatic cancer |
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