Kd. Miller et al., A PHASE-II STUDY OF WEEKLY ORAL METHOTREXATE AND ZIDOVUDINE (AZT) IN ADVANCED ADENOCARCINOMA OF THE PANCREAS AND HEPATOCELLULAR-CARCINOMA, Investigational new drugs, 14(2), 1996, pp. 207-212
From January 1992 through May 1993, 31 patients with adenocarcinoma of
the pancreas or hepatocellular carcinoma were treated with weekly ora
l methotrexate (7.5 mg/M(2) every 6 hours for 6 doses) and continuous
oral AZT (200 mg four times daily). Patients were treated for a total
of 6 months or until disease progression. The median age was 66 (range
44-79) and the median KPS was 80. No patient had received prior chemo
therapy. Hematologic toxicity was severe with 50% of patients developi
ng hemoglobins less than 8 gm/dl and 70% with granulocyte counts less
than 1000 per mm(3). One patient achieved a radiographic complete remi
ssion and 2 had stable disease. Two-thirds of patients progressed with
in 2 months of beginning therapy. The combination of methotrexate and
AZT is an inactive regimen in pancreatic and hepatocellular carcinoma
and is associated with considerable toxicity.