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 DX-8951f in treating patients who have liver cancer.

Condition	Treatment or Intervention	Phase
recurrent adult primary liver cancer advanced adult primary liver cancer localized resectable adult primary liver cancer adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer	Drug: exatecan mesylate	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate the antitumor activity of DX-8951f in terms of antitumor response, response duration, and survival in patients with hepatocellular carcinoma. II. Assess the quantitative and qualitative toxicities of this treatment regimen in this patient population. III. Evaluate the pharmacokinetics of DX-8951 in plasma.

PROTOCOL OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 12 months.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed hepatocellular carcinoma with or without evidence of unresectable extrahepatic metastasis; Previously untreated disease OR Progressive disease after first line chemotherapy
• Bidimensionally measurable disease by CT scan, chest x-ray, or MRI of the abdomen
• No brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent biologic therapy
• Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy and recovered; No prior camptothecin analogues; No other concurrent chemotherapy
• Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No concurrent radiotherapy
• Surgery: At least 4 weeks since prior major surgery and recovered; No concurrent surgery
• Other: No other concurrent anticancer therapy; At least 4 weeks since prior investigational drugs (including analgesics or antiemetics); No other investigational drugs during or within 28 days after final dose of study drug

--Patient Characteristics--

• Age: 16 and over
• Performance status: ECOG 0-2
• Life expectancy: At least 12 weeks
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 80,000/mm3; Hemoglobin at least 9.0 g/dL
• Hepatic: Bilirubin no greater than 2.0 mg/dL; Albumin at least 2.8 g/dL SGOT/SGPT no greater than 5 times upper limit of normal (ULN); PT/INR no greater than 1.5 times ULN if not on coumadin therapy
• Renal: Creatinine no greater than 1.5 mg/dL
• Cardiovascular: No active congestive heart failure; No uncontrolled angina; No myocardial infarction within the past 6 months
• Other: No concurrent serious infection; No other life threatening illness; No overt psychosis or mental disability that would preclude informed consent; No other malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception 1 month prior to and during the study

Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
Texas
      Cancer Therapy & Research Center, San Antonio,  Texas,  78229,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Robert L. DeJager,  Study Chair,  Daiichi Pharmaceuticals   

Study ID Numbers:  CDR0000067329; DAIICHI-8951A-PRT016; MDA-ID-99145; MSKCC-99058; UCHSC-00891
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004108
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08