A phase II study of 9-nitrocamptothecin in patients with advanced pancreatic adenocarcinoma

Citation
Mm. Konstadoulakis et al., A phase II study of 9-nitrocamptothecin in patients with advanced pancreatic adenocarcinoma, CANC CHEMOT, 48(5), 2001, pp. 417-420
Citations number
14
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Oncology,"Onconogenesis & Cancer Research
Journal title
CANCER CHEMOTHERAPY AND PHARMACOLOGY
ISSN journal
0344-5704 → ACNP
Volume
48
Issue
5
Year of publication
2001
Pages
417 - 420
Database
ISI
SICI code
0344-5704(200111)48:5<417:APISO9>2.0.ZU;2-O
Abstract
Purpose: Preclinical and phase I clinical data suggest that 9-nitrocamptoth ecin (9NC) is an agent with potential anticancer activity. A phase II study was undertaken in order to evaluate the potential benefit of oral 9NC admi nistration in patients with advanced pancreatic cancer. This was the first clinical study of 9NC in Europe. Methods: A total of 19 consecutive patient s with locally advanced or metastatic adenocarcinoma were enrolled (8 males and 11 females, aged 37-73 years). The patients were given 9NC orally five times a week, once a day. The end-points of this study were toxicity, obje ctive response rate, subjective response rate (i.e. pain control, performan ce status and body weight), and survival. Results: An objective response wa s documented in 4 of the 14 evaluable patients (28.6%), while a subjective response was observed in 13 patients (92.9%). Overall median survival was 2 1 weeks (31 weeks in the group of 14 patients evaluable for response), and the 1-year survival was 16.7% and 23.1%, respectively. Toxicity leading to temporary discontinuation of 9NC was encountered in seven patients (36.8%), all related to a prior dose increase, while milder toxicity was observed i n eight patients(42.1%). Conclusions: 9NC administered orally to patients w ith advanced pancreatic cancer gave promising results, while the toxicity o f the therapy was mild and readily overcome. A larger scale clinical trial should be organized in order to establish the potential benefit of 9NC in p atients with pancreatic adenocarcinoma.