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

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