Phase II Trial of Pyrazoloacridine (PZA) in Previously Untreated Hepatocellular Carcinoma (HCC) Patients
OBJECTIVES: I. Determine the response rate, duration, and survival in previously untreated
patients with hepatocellular carcinoma treated with pyrazoloacridine (PZA). II. Determine
the nature, degree, and duration of toxic effects of PZA in these patients.
OUTLINE: Patients receive pyrazoloacridine IV over 3 hours every 3 weeks. The minimum
treatment period is 2 courses with tumor restaging at 6 weeks. Patients with complete
remission (CR) or partial remission (PR) may continue on treatment until refractory (PR) or
for at least 3 additional courses (CR). Patients with stable disease continue on therapy for
at least 2 more courses. Patients are followed until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 24
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Yehuda Z. Patt, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board