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Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed

2014-07-23 21:52:37 | BioPortfolio

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have liver cancer that cannot be surgically removed.

Description

OBJECTIVES:

- Determine the 16-week progression-free survival of patients with unresectable hepatocellular carcinoma treated with erlotinib.

- Determine the objective response rate, rate and duration of stable disease, and time to progression in patients treated with this drug.

- Determine the median and overall survival of patients treated with this drug.

- Determine the pharmacokinetic and pharmacodynamic profiles of this drug in these patients.

- Determine the safety and tolerability of this drug in these patients.

- Correlate response to this drug with patient characteristics (e.g., age, disease stage, viral hepatitis status, pathologic grade of cirrhosis, Childs-Pugh status, performance status, serum values of alpha-fetoprotein, bilirubin, transaminases, and albumin, epidermal growth factor receptor expression, and development of skin rash during therapy).

OUTLINE: Patients are stratified according to epidermal growth factor receptor expression (low, 0-1+ vs high, 2-3+).

Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study within 25-50 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Liver Cancer

Intervention

erlotinib hydrochloride

Location

M.D. Anderson Cancer Center at University of Texas
Houston
Texas
United States
77030-4009

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:52:37-0400

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Medical and Biotech [MESH] Definitions

A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.

Tumors or cancer of the LIVER.

A pharmaceutical preparation of sitagliptin phosphate and metformin hydrochloride that is used in the treatment of TYPE 2 DIABETES.

A naturally occurring compound that has been of interest for its role in osmoregulation. As a drug, betaine hydrochloride has been used as a source of hydrochloric acid in the treatment of hypochlorhydria. Betaine has also been used in the treatment of liver disorders, for hyperkalemia, for homocystinuria, and for gastrointestinal disturbances. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1341)

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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