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Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer

2014-08-27 03:17:55 | BioPortfolio

Summary

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than sorafenib tosylate alone in treating liver cancer.

PURPOSE: This randomized phase III trial is studying sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with locally advanced or metastatic liver cancer.

Description

OBJECTIVES:

Primary

- To compare the overall survival of patients with locally advanced or metastatic hepatocellular carcinoma treated with sorafenib tosylate with vs without doxorubicin hydrochloride.

Secondary

- To compare the time to progression in patients treated with these regimens.

- To compare the progression-free-survival of patients treated with these regimens.

- To compare the tumor response using RECIST criteria in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to hepatitis status (no hepatitis vs hepatitis B vs hepatitis C vs hepatitis B and C) and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive doxorubicin hydrochloride IV on day 1 and oral sorafenib tosylate twice daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive oral sorafenib tosylate twice daily in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive oral sorafenib tosylate twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 2 years.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Liver Cancer

Intervention

doxorubicin hydrochloride, sorafenib tosylate

Location

Providence Cancer Center at Providence Hospital
Mobile
Alabama
United States
36608

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:55-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the LIVER.

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.

Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.

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

An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA.

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