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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Once daily by mouth on days 1-14, repeat every 21 days for 2 courses.
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States
Maximum Tolerated Dose (MTD) of TAC-101
Time frame: 60 Days
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