Comparison Study of Sorafenib and 5-fluorouracil/Mitomycin for Metastatic Hepatocellular Carcinoma

NCT01171482 | Terminated Phase 2

• 1 other identifier: 07-2010-010
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the efficacy of sorafenib to 5-fluorouracil/mitomycin in HCC patients with pulmonary metastasis whose intrahepatic tumors has been controlled with locoregional therapies.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  every 8 weeks

Secondary Outcomes (4)

• Time-to-progression (TTP)

  every 8 weeks

• Objective tumor response rate

  Determined by CT scan at the end of every 2 cycles until progressive disease is documented or intolerable toxicity occurs

• Adverse event rates and the toxicities

  every 4 weeks

• Overall survival

  every 8 weeks

Study Arms (2)

The FM group

EXPERIMENTAL

Patients in the FM group will be administered 5-FU plus mitomycin

Drug: 5-FU; Drug: Mitomycin

The sorafenib group

ACTIVE COMPARATOR

Patients in the sorafenib group will be administered sorafenib

Drug: sorafenib

Interventions

5-FU DRUG

15mg/kg/day continuous IV from day 1 to day 6 every 28 days.

Also known as: 5-fluorouracil

The FM group

Mitomycin DRUG

4mg/day IV push from day 1 to day 4 every 28 days

The FM group

sorafenib DRUG

400 mg BID every 28 days

Also known as: Nexavar

The sorafenib group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
• Patients with at least one, bi-dimensionally measurable, pulmonary metastasis without intrahepatic viable tumor (Viable tumor is defined as uptake of contrast agent in the arterial phase of dynamic CT or MRI.)
• Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) to non-target lesions are eligible
• Age : 20 years to 80 years
• ECOG Performance Status of 0 to 1
• Child-Pugh class A or B (Child-Pugh score 7)
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
• Hb ≧ 9 g/dL
• Absolute neutrophil count \> 1000/mm3
• Platelet count ≧ 60,000 /mm3
• Adequate clotting function: INR \< 1.5
• Hepatic: AST and ALT \< 5 X ULN
• Renal: serum creatinine \< 1.7mg/dL
• Bilirubin ≦ 3 mg/dL

You may not qualify if:

• Patients with diffuse infiltrative type of HCC that are poorly defined
• Presence of hepatic encephalopathy and intractable ascites
• Patients who are on a liver transplant list
• The patient has received prior systemic chemotherapy
• History of organ allograft
• Active clinically serious infections (\> grade 2 NCI-CTC version 3.0), including spontaneous bacterial peritonitis
• History of cardiac disease: congestive heart failure \> NYHA class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed), cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension and diabetes mellitus
• Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted
• HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Fluorouracil; Mitomycin; Sorafenib

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)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• Jung-Hwan Yoon, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 28, 2010
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)