Sorafenib Plus Tegafur/Uracil (UFUR®) for Hepatocellular Carcinoma (HCC)

NCT00464919 | Completed Phase 2 DMC

• 1 other identifier: 950914
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The prognosis for patients with metastatic or locally advanced hepatocellular carcinoma (HCC) is poor. The role of conventional systemic chemotherapy has been very limited because most chemotherapeutic agents are in-effective and relative toxic to HCC patients who tend to have poor organ function reserves due to liver cirrhosis. The molecular-targeted therapy, which aims at deranged signaling pathways of cancer cells or their microenvironment, holds promise for HCC. Sorafenib (BAY 43-9006), a novel bi-aryl urea, is a potent inhibitor of VEGFR2 and Raf kinase. The clinical activity of sorafenib in HCC has been tested in a phase II study (Bayer study 10874), which enrolled a total of 137 advanced HCC patients. There were 4% of documented partial response, 5% of minor response, and 55% of stable disease. The 6- month progression -free for the cohort was 40%. Currently, there are two on-going large-scale randomized trials of sorafenib in advanced HCC patients worldwide.

Conditions

Hepatocellular Carcinoma

Keywords

Advance, hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• To determine the progression- free survival of sorafenib plus tegafur/uracil (UFUR®) for the treatment of advanced or metastatic HCC.

  2007~2008

Secondary Outcomes (6)

• The 6-month progression-free survival rate.

  2007~2008

• The objective tumor response rate.

  2007~2008

• The disease stabilization rate (complete response + partial response + stable disease for at least 2 months).

  2007~2008

• The overall survival.

  2007~2008

• The safety profile.

  2007~2008

Study Arms (1)

A

EXPERIMENTAL

Drug: Sorafenib; Drug: tegafur/uracil (UFUR®)

Interventions

Sorafenib DRUG

A

tegafur/uracil (UFUR®) DRUG

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• ECOG PS 0-2;
• Histologically or cytologically documented unresectable and/or metastatic HCC;
• Measurable disease by RECIST criteria;
• Previous local therapy completed \> 6 weeks;
• Any acute toxicity (CTC-AE) \< grade 1;
• Child-Pugh A;
• Liver transaminases ≤ 5 x ULN;
• Albumin ≥ 2.8 g/dl;
• Serum total bilirubin ≤ 3 mg/dl;
• INR ≤ 2.3 or PT ≤ 6 seconds above control;
• WBC ≥ 3,000/µl;
• ANC ≥ 1,500/µl;
• Platelets ≥ 100,000/µl;
• Hb ≥ 8.5 g/dl;

You may not qualify if:

• Metastatic brain/leptomeningeal tumors;
• Prior or concomitant systemic anti-cancer treatment for HCC, including:
• Systemic chemotherapy (TACE is allowed)
• Immunotherapy
• Hormonal therapy (hormonal therapy used for supportive used is allowed)
• Raf-kinase inhibitors
• MEK inhibitors
• Farnesyl transferase inhibitors
• VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
• Investigational anti-cancer agents
• Severe and/or uncontrolled medical conditions:
• Uncontrolled high blood pressure
• History of poor compliance with anti-hypertensive agents
• Active or uncontrolled infection
• Unstable angina

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• Hsu CY, Shen YC, Yu CW, Hsu C, Hu FC, Hsu CH, Chen BB, Wei SY, Cheng AL, Shih TT. Dynamic contrast-enhanced magnetic resonance imaging biomarkers predict survival and response in hepatocellular carcinoma patients treated with sorafenib and metronomic tegafur/uracil. J Hepatol. 2011 Oct;55(4):858-65. doi: 10.1016/j.jhep.2011.01.032. Epub 2011 Feb 19.

  PMID: 21338641 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib; Tegafur; Uracil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Pyrimidinones; Pyrimidines

Study Officials

• Chih-Hung Hsu, M.D.Ph.D

  Department of Oncology, National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: April 1, 2007
• Study Completion: March 1, 2009
• Last Updated: July 7, 2009

Record last verified: 2009-06

Locations

TW (1)