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

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ClinicalTrials.gov Identifier: NCT01953406
Recruitment Status : Withdrawn (No participants were enrolled. Therefore, we stop this study, prematurely.)
First Posted : October 1, 2013
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 : November 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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 Name: 5-FU

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




Primary Outcome Measures :
  1. Time-to-progression(TTP)of lung metastasis [ Time Frame: every 12 weeks, up to 36 weeks ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: every 12 weeks, up to 36 weeks ]
  2. Response rates(CR + PR)of lung metastasis [ Time Frame: every 12 weeks, up to 36 weeks ]
  3. progression free survival [ Time Frame: every 12 weeks, up to 36 weeks ]
  4. Time to recurrence of intrahepatic tumor [ Time Frame: every 12 weeks, up to 36 weeks ]
  5. Disease control rates (CR + PR + SD)of lung metastasis [ Time Frame: every 12 weeks, up to 36 weeks ]

Other Outcome Measures:
  1. Adverse Events [ Time Frame: every 12 weeks, up to 36 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953406


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jung-Hwan Yoon, M.D., Ph.D. Seoul National University Hospital

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Responsible Party: Jung-Hwan Yoon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01953406     History of Changes
Other Study ID Numbers: LUNG M_FM
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016

Keywords provided by Jung-Hwan Yoon, Seoul National University Hospital:
hepatocellular carcinoma
lung metastasis
5-fluorouracil/mitomycin

Additional relevant MeSH terms:
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Carcinoma
Neoplasm Metastasis
Neoplasms, Second Primary
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Fluorouracil
Mitomycins
Mitomycin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors