© 2005 European Society for Medical Oncology
Original article |
Phase II study of troxacitabine in chemotherapy-naïve patients with advanced cancer of the pancreas
Gastrointestinal tumors
1 Centre Hospitalier de l'Université de Montréal, St-Luc Hospital, Montreal, Canada; 2 Leicester Royal Infirmary, Leicester; 3 Christie Hospital, Manchester, UK; 4 Jewish General Hospital, Montreal; 5 London Regional Cancer Center, London; 6 Sacré-Coeur Hospital, Montreal, Canada; 7 Belfast City Hospital, Belfast, UK; 8 Shire Pharmaceutical Development, Rockville, MD, USA; 9 Princess Margaret Hospital, Toronto, Canada
* Correspondence to: Dr M. Moore, Department of Medical Oncology, Princess Margaret Hospital, 610 University Avenue, Toronto, Ontario M5G 2M9, Canada. Tel: +1-416-946-2263; Fax: +1-416-946-2082; Email: malcolm.moore{at}uhn.on.ca
Background: Troxacitabine (TroxatylTM) is a novel L-enantiomer nucleoside analog with activity in pancreatic cancer xenograft models.
Patients and methods: Troxacitabine 1.5 mg/m2 was administered by 30-min infusions daily x5 every 4 weeks to 54 patients with advanced pancreatic cancer. Patients were evaluated for objective tumor response, time to tumor progression (TTP), changes in tumor marker CA 19-9, survival, safety, pain, analgesic consumption, Karnofsky performance status and weight change.
Results: Median TTP was 3.5 months (95% CI 2.0–3.8), median survival 5.6 months (95% CI 4.9–7.4), and the 1 year survival rate 19%. Best responses were stable disease in 24 patients with eight patients having stable disease for at least 6 months (15%). A 50% or greater decrease in CA 19-9 was seen in seven of 44 assessed patients (16%). Grade 3 and 4 neutropenia were observed in 37% and 30% of patients with one episode of febrile neutropenia. The most common drug-related non-hematological toxic effects reported were cutaneous, with 22% and 6% of patients reporting grade 2 and 3 skin rash, respectively and 4% grade 2 hand–foot syndrome.
Conclusion: Troxacitabine administered by a bolus daily x5 monthly regimen has modest activity in advanced pancreatic adenocarcinoma.
Key words: nucleoside analog, pancreatic cancer, phase II, troxacitabine
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