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RATIONALE: TAC-101 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: This phase I/II trial is studying the side effects and best dose of TAC-101 and to see how well it works in treating patients with advanced hepatocellular carcinoma (liver cancer). OBJECTIVES: Phase I * Primary * Determine the maximum tolerated dose (MTD) of TAC-101 in patients with advanced hepatocellular carcinoma. * Determine the safety of 2 consecutive courses of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Determine the toxic and adverse effects profile of this drug in these patients. Phase II * Primary * Determine the objective antitumor response rate in patients treated with this drug at the MTD. * Secondary * Determine the overall survival time of patients treated with this drug. * Determine the time to disease progression in patients treated with this drug. * Determine the duration of observed objective response, using WHO criteria and measurements of serum alpha-fetoprotein concentrations, in patients treated with this drug. * Determine the time to treatment failure in patients treated with this drug. * Determine the safety and tolerability of intermittent treatment with this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. * Phase I: Patients receive oral TAC-101 once daily on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of TAC-101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive oral TAC-101 at the MTD (determined in phase I) once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 35-60 days. PROJECTED ACCRUAL: A total of 6-18 patients for the phase I portion and 21-41 patients for the phase II portion will be accrued for this study.
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
is designated in this study