TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral TAC-101 in Patients With Advanced Hepatocellular Carcinoma|
- Maximum Tolerated Dose (MTD) of TAC-101 [ Time Frame: 60 Days ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2001|
|Study Completion Date:||August 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
Oral TAC-101 daily Days 1-14, repeats every 21 days for 2 courses.
Once daily by mouth on days 1-14, repeat every 21 days for 2 courses.
- 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.
- Determine the objective antitumor response rate in patients treated with this drug at the MTD.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077142
|United States, Texas|
|MD Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Melanie B. Thomas, MD||M.D. Anderson Cancer Center|