TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed hepatocellular carcinoma
• •At least 1 previously unirradiated, bidimensionally measurable lesion greater than 20 mm by MRI or conventional CT scan OR at least 10 mm by spiral CT scan
• •Patients with CNS involvement must have completed appropriate treatment and have no progressive neurologic deficits within the past 28 days
• •No carcinomatous meningitis
• •PATIENT CHARACTERISTICS:
• •Age
• •18 to 80
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •More than 12 weeks
• •Hematopoietic
• •Hemoglobin ≥ 10.0 g/dL
• •WBC ≥ 2,000/mm\^3
• •Absolute neutrophil count ≥ 1,000/mm\^3
• •Platelet count ≥ 40,000/mm\^3
• •No abnormal bleeding or clotting
• •Hepatic
• •No grade C Child-Pugh cirrhosis
• •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• •Albumin ≥ 2.8 g/dL
• •INR ≤ 1.5 times ULN
• •Bilirubin ≤ 2.0 mg/dL
• •Renal
• •Creatinine ≤ 1.5 times ULN
• •Cardiovascular
• •No prior deep vein thrombosis
• •No prior superficial venous thrombosis
• •No family history of thromboembolism in a first-degree relative
• •No lower extremity thromboses by Doppler ultrasound (unless a subsequent venous angiography confirms a false positive ultrasound)
• •Pulmonary
• •No prior pulmonary embolism
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception, except oral contraceptives containing estrogen
• •Fasting triglycerides ≤ 400 mg/dL for men or ≤ 325 mg/dL for women
• •No other malignancy within the past 3 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix
• •No uncontrolled metabolic disorders, other nonmalignant organ or systemic disease, or secondary effects of cancer that induce a high medical risk
• •No known allergy or hypersensitivity to TAC-101 or its components
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No prior thalidomide
• •No prior putative antiangiogenesis therapy
• •Prior interferon allowed
• •Chemotherapy
• •No more than 2 prior chemotherapy regimens
• •Endocrine therapy
• •No concurrent estrogen products
• •Radiotherapy
• •See Disease Characteristics
• •More than 21 days since prior radiotherapy, except small portal radiotherapy used for the palliation of isolated, symptomatic, osseous metastases
• •No prior radiotherapy to evaluable lesions
• •No concurrent radiotherapy unless for bone pain that is present before beginning study
• •Surgery
• •Not specified
• •Other
• •Prior anticancer treatment allowed provided there is clear evidence of progressive disease after the most recent treatment
• •More than 21 days since prior anticancer therapy and recovered
• •No more than 2 prior treatment regimens
• •No concurrent therapeutic anticoagulants
• •* Concurrent low-dose warfarin for prophylactic care of indwelling venous access devices allowed
• •No concurrent azoles or tetracyclines
• •No concurrent medications known or suspected to increase risk of venous thromboembolism
• •No other concurrent retinoids