Liver Cancer Clinical Trial
Official title:
Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral TAC-101 in Patients With Advanced Hepatocellular Carcinoma
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.
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