Chemotherapy in Treating Patients With Unresectable Primary or Metastatic Kidney Cancer
Chemotherapy in Treating Patients With Unresectable Primary or Metastatic Kidney Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
 they stop growing or die.

 PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients
 who have unresectable primary or metastatic kidney cancer that has not been previously
 treated.
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 months.
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
 depression

 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