The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma, Lung Metastasis
Status
Withdrawn
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
5-fluorouracil
Mitomycin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, lung metastasis, 5-fluorouracil/mitomycin
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The 5-fluorouracil/mitomycin group
Arm Description
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
Outcomes
Primary Outcome Measures
Time-to-progression(TTP)of lung metastasis
Secondary Outcome Measures
Overall survival
Response rates(CR + PR)of lung metastasis
progression free survival
Time to recurrence of intrahepatic tumor
Disease control rates (CR + PR + SD)of lung metastasis
Full Information
NCT ID
NCT01953406
First Posted
September 21, 2013
Last Updated
April 26, 2016
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01953406
Brief Title
The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma
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 Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No participants were enrolled. Therefore, we stop this study, prematurely.
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Lung Metastasis
Keywords
hepatocellular carcinoma, lung metastasis, 5-fluorouracil/mitomycin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The 5-fluorouracil/mitomycin group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
5-fluorouracin 15mg/kg/day D1-6 civ till progression, every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Mitomycin
Intervention Description
Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks
Primary Outcome Measure Information:
Title
Time-to-progression(TTP)of lung metastasis
Time Frame
every 12 weeks, up to 36 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
every 12 weeks, up to 36 weeks
Title
Response rates(CR + PR)of lung metastasis
Time Frame
every 12 weeks, up to 36 weeks
Title
progression free survival
Time Frame
every 12 weeks, up to 36 weeks
Title
Time to recurrence of intrahepatic tumor
Time Frame
every 12 weeks, up to 36 weeks
Title
Disease control rates (CR + PR + SD)of lung metastasis
Time Frame
every 12 weeks, up to 36 weeks
Other Pre-specified Outcome Measures:
Title
Adverse Events
Time Frame
every 12 weeks, up to 36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Hwan Yoon, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma
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