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TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)

2014-08-27 03:54:37 | BioPortfolio

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).

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Liver Cancer

Intervention

TAC-101

Location

MD Anderson Cancer Center at University of Texas
Houston
Texas
United States
77030-4009

Status

Completed

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:37-0400

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A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)

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