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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Taiho Pharmaceutical Co., Ltd.

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