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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01953406

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Lung Metastasis	Drug: 5-fluorouracil Drug: Mitomycin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study Evaluating the Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma Who Had Progressive Disease With Sorafenib

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 5-fluorouracil 5-fluorouracin 15mg/kg/day D1-6 civ till progression, every 4 weeks Other Names: 5-FU Drug: Mitomycin Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks

Arm

Intervention/Treatment

Experimental: 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

Drug: 5-fluorouracil

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

Other Names:

5-FU

Drug: Mitomycin

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

Outcome Measures

Primary Outcome Measures

Time-to-progression(TTP)of lung metastasis [every 12 weeks, up to 36 weeks]

Secondary Outcome Measures

Overall survival [every 12 weeks, up to 36 weeks]
Response rates(CR + PR)of lung metastasis [every 12 weeks, up to 36 weeks]
progression free survival [every 12 weeks, up to 36 weeks]
Time to recurrence of intrahepatic tumor [every 12 weeks, up to 36 weeks]
Disease control rates (CR + PR + SD)of lung metastasis [every 12 weeks, up to 36 weeks]

Other Outcome Measures

Adverse Events [every 12 weeks, up to 36 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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