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
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.