The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma

NCT ID: NCT01953406

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2015-11-30

Brief Summary

The aim of this study is to evaluate the efficacy of 5-fluorouracil + Mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.

Detailed Description

Extrahepatic metastasis of hepatocellular carcinoma has recently been paradoxically increasing due to increased survival with effective locoregional therapies. Sorafenib is the first systemic agent that has demonstrated a significant survival benefit in patients with advanced HCC; however, the modest improvement of 3 months is far from satisfactory. There is no convincing evidence, to date, that systemic chemotherapy when tumor progresses after sorafenib therapy improves overall survival. The combination of anticancer agents is important to achieve favourable clinical results. For patients with metastatic liver cancer or HCC, some studies have discussed the effectiveness of 5-fluorouracil/mitomycin(FM). However, few studies have examined the actual FM regimen for HCC.

The aim of this study is to evaluate the efficacy of 5-fluorouracil/mitomycin for the patients with pulmonary metastasis of hepatocellular carcinoma who had progressive disease with sorafenib.

Conditions

Hepatocellular Carcinoma; Lung Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The 5-fluorouracil/mitomycin group

Systemic chemotherapy with 5-fluorouracil/mitomycin 5-fluorouracin 15mg/kg/day D1-6 civ + Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks

Group Type: EXPERIMENTAL

5-fluorouracil

Intervention Type: DRUG

5-fluorouracin 15mg/kg/day D1-6 civ till progression, every 4 weeks

Mitomycin

Intervention Type: DRUG

Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks

Interventions

5-fluorouracil

5-fluorouracin 15mg/kg/day D1-6 civ till progression, every 4 weeks

Intervention Type: DRUG

Mitomycin

Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks

Intervention Type: DRUG

Other Intervention Names

5-FU

Eligibility Criteria

Inclusion Criteria

• Patients who have received previous local therapy treatments for the intrahepatic hepatocellular carcinoma (RFA, PEI, cryoablation, surgery, resection) and who don't have any viable intrahepatic tumor within 3 months of imaging (dynamic liver CT or liver MRI) after the locoregional therapy
• Patients who have measurable lung metastasis
• Patients who have received their last dose of sorafenib more than 14 days before and who had progressive disease of lung metastasis with sorafenib
• Patients who have risk factors of hepatocellular carcinoma (chronic hepatitis B, chronic hepatitis C, liver cirrhosis)
• Age : 18 years to 80 years
• ECOG Performance Status of 0 to 2
• Child-Pugh class A,B (Child-Pugh score 5-9)
• Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

• WBC count > 1,000/mm3
• Absolute neutrophil count > 500/mm3
• Hb > 7.0 g/dL
• Platelet count > 50,000 /mm3
• Bilirubin < 3 mg/dL
• Adequate clotting function: INR < 2.3 or < 6sec

Exclusion Criteria

• Child-Pugh score > 10
• ECOG Performance Status > 3
• History of organ allograft
• Patients with uncontrolled co-morbidity which needs treatment
• Patients who have received prior systemic chemotherapy except sorafenib

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jung-Hwan Yoon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jung-Hwan Yoon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

LUNG M_FM

Identifier Type: -

Identifier Source: org_study_id