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

April 26, 2016 updated by: Jung-Hwan Yoon, Seoul National University Hospital

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time-to-progression(TTP)of lung metastasis
Time Frame: every 12 weeks, up to 36 weeks
every 12 weeks, up to 36 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: every 12 weeks, up to 36 weeks
every 12 weeks, up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 21, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUNG M_FM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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