TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
Liver Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, Oral TAC-101
Eligibility 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
Sites / Locations
- MD Anderson Cancer Center at University of Texas
Arms of the Study
Arm 1
Experimental
TAC-101
Oral TAC-101 daily Days 1-14, repeats every 21 days for 2 courses.