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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01953406
• Other study ID #: LUNG M_FM
• Status: Withdrawn
• Phase: Phase 2
• First received: September 21, 2013
• Last updated: April 26, 2016
• Start date: November 2015
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Lung Metastasis
• Neoplasm Metastasis

Intervention

Drug:
• 5-fluorouracil
5-fluorouracin 15mg/kg/day D1-6 civ till progression, every 4 weeks
• Mitomycin
Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events		every 12 weeks, up to 36 weeks	Yes
Primary	Time-to-progression(TTP)of lung metastasis		every 12 weeks, up to 36 weeks	No
Secondary	Overall survival		every 12 weeks, up to 36 weeks	No
Secondary	Response rates(CR + PR)of lung metastasis		every 12 weeks, up to 36 weeks	No
Secondary	progression free survival		every 12 weeks, up to 36 weeks	No
Secondary	Time to recurrence of intrahepatic tumor		every 12 weeks, up to 36 weeks	No
Secondary	Disease control rates (CR + PR + SD)of lung metastasis		every 12 weeks, up to 36 weeks	No