Purpose: Pyrazoloacridine (PZA) is an acridine derivative selected for
clinical development because of broad preclinical antitumor activity
and solid tumor selectivity. Phase I evaluations with PZA have demonst
rated predictable toxicity and suggested clinical efficacy. A phase Il
trial in patients with previously untreated advanced pancreatic cance
r was conducted. Methods: PZA was administered at a dose of 750 mg/m(2
) intravenously over 3 hours every 21 days. Seventeen patients were tr
eated receiving a total of 46 courses of PZA. Results: Of the 15 patie
nts evaluable for response, no responses were observed (0% response ra
te, 95% confidence interval 0-22%). Major toxicities directly attribut
able to PZA included moderate neutropenia and mild neurotoxicity. Conc
lusion: PZA at this dose and schedule of administration was inactive i
n patients with pancreatic carcinoma.