TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
- Registration Number
- NCT00077142
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAC-101 TAC-101 Oral TAC-101 daily Days 1-14, repeats every 21 days for 2 courses.
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) of TAC-101 60 Days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MD Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States