Clinical trial NCT01953406: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lung Metastasis
Keywords: hepatocellular carcinoma
lung metastasis
5-fluorouracil/mitomycin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time-to-progression(TTP)of lung metastasis
timeFrame: every 12 weeks, up to 36 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: every 12 weeks, up to 36 weeks
measure: Response rates(CR + PR)of lung metastasis
timeFrame: every 12 weeks, up to 36 weeks
measure: progression free survival
timeFrame: every 12 weeks, up to 36 weeks
measure: Time to recurrence of intrahepatic tumor
timeFrame: every 12 weeks, up to 36 weeks
measure: Disease control rates (CR + PR + SD)of lung metastasis
timeFrame: every 12 weeks, up to 36 weeks
Other outcomes:
measure: Adverse Events
timeFrame: every 12 weeks, up to 36 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jung-Hwan Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: