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.

Condition	Treatment or Intervention	Phase
advanced adult primary liver cancer liver metastases adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer	Drug: pyrazoloacridine	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY 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

--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

--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

Study chairs or principal investigators

Yehuda Z. Patt,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000066822; MDA-DM-98107; NCI-T98-0031
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003714
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08