Know Cancer

forgot password

Phase II Trial of Pyrazoloacridine (PZA) in Previously Untreated Hepatocellular Carcinoma (HCC) Patients

Phase 2
Not Enrolling
Liver Cancer, Metastatic Cancer

Thank you

Trial Information

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

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven unresectable primary or metastatic
hepatocellular carcinoma Measurable disease by CT or MRI scan No tense ascites Brain
metastases allowed with proper treatment

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Zubrod
0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL
Albumin at least 3 g/dL Alkaline phosphatase no greater than 3 times upper limit of normal
Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile
patients must use effective contraception No significant infection Peripheral neurologic
toxicity limited to paresthesia and decreased vibratory sense without motor weakness
allowed Constipation managed with laxatives without evidence of bowel obstruction allowed
No psychological disorders including delirium, confusion, suicidal ideation, or untreated

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior palliative radiotherapy
allowed At least 3 weeks since prior radiotherapy and recovered Surgery: Recovered from
any prior surgery

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Response

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Yehuda Z. Patt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Liver Cancer
  • Metastatic Cancer
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • liver metastases
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Carcinoma, Hepatocellular