Phase II trial of fazarabine (arabinofuranosyl-5-azacytidine) in patients with advanced pancreatic adenocarcinoma.
We conducted a phase II evaluation of fazarabine 1.75-2.0 mg/m2/hr over 72 hours every 28 days in 14 previously untreated patients with advanced adenocarcinoma of the pancreas. The initial dose was 1.75 mg/m2/hr in 10 patients, and 2.0 mg/m2/hr in 4 patients. The dose was escalated in 8 patients, including all 4 who started at the higher dose level. Toxicity was unexpectedly mild. The median WBC nadir was 4.4 (range: 2.4-15.8) x 10(3)/microliters, the median absolute neutrophil nadir was 3.2 (range: 0.9-13.0) x 10(3)/microliters, and the median platelet count was 134.0 (range: 48.0-291.0) x 10(3)/microliters. Gastrointestinal toxicity was generally mild. No major responses were seen, excluding, with 95% confidence, a response rate in excess of 20%.
Casper
E S
ES
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
Schwartz
G K
GK
Kelsen
D P
DP
D000230:Adenocarcinoma / Q000188:drug therapy*; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001374:Azacitidine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D007260:Infusion Pumps; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents; C022121:fazarabine; D001374:Azacitidine