TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
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|ClinicalTrials.gov Identifier: NCT00077142|
Recruitment Status : Completed
First Posted : February 11, 2004
Last Update Posted : July 30, 2012
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).
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: TAC-101||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral TAC-101 in Patients With Advanced Hepatocellular Carcinoma|
|Study Start Date :||April 2001|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||August 2005|
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.
- Maximum Tolerated Dose (MTD) of TAC-101 [ Time Frame: 60 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|