TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
Condition: Liver Cancer
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

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).
    

Detailed description: 
      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.
    

Intervention name(s): TAC-101
Intervention type(s): Drug
Intervention description(s): Once daily by mouth on days 1-14, repeat every 21 days for 2 courses.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced adult primary liver cancer; recurrent adult primary liver cancer; adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer; Oral TAC-101