Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 7 for:    "Hepatocellular carcinoma (fibrolamellar variant)"

Study of Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Carcinoma (Fibrolam)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01215565
Recruitment Status : Terminated (lack of inclusion)
First Posted : October 6, 2010
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The purpose of this study is to evaluate the antitumor activity of sunitinib in patients with advanced/inoperable fibrolamellar hepatocellular carcinoma.

Rationale: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Fibrolamellar Hepatocellular Carcinoma Drug: Sutent Phase 2

Detailed Description:

Fibrolamellar hepatocellular carcinoma is variant rare of hepatocellular carcinoma witch distinct clinical, histological and prognostic features from conventional hepatocellular carcinoma. This entity typically occurs in young adults with no underlying hepatitis or cirrhosis. Surgical resections could be proposed in some referral centers and this in cases of localized tumors. However, in cases of postoperative recurrence, "salvage" resection is not often possible. Overall prognosis remains poor, because of its primary chemoresistance and early recurrence of metastasis.

Sunitinib (SUTENT) is a potent tyrosine kinase inhibitor, with double antiangiogenic and antitumor activity, targeting multiple receptors as VEGF-R, PDGF-R, KIT and FLT3.

Since 2006, Sunitinib has been approved to treat advanced kidney cancer also called advanced renal cell carcinoma (a typically chemoresistant disease for which there no active treatment was available).

Several targets of sunitinib are overexpressed hepatocellular carcinoma lines as shown in the Literature review and pathological studies.

Otherwise, the overexpression of PDGFR and VEGFR correlates with recurrence and invasion in HCC. Finally, sunitinib showed an interesting antitumor activity in patients with conventional advanced HCC.

Thereby, it seems important to study how well the sunitinib, a potent antitumor and antiangiogenic agent, works in treating patients with advanced or inoperable fibrolamellar hepatocellular carcinoma especially, this setting lacks effective therapies. Furthermore, it seems urgent to conduct translational research and assessment to identify predictive biomarkers of response.

In this study, orally sunitinib at dosed of 50 mg daily will be administrated to patients for 4 weeks, followed by 2 weeks of wash out. This administration schedule is based on the phase I study of sunitinib.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter National Phase II Open Study Coupled With Translational Assessment of Biomarkers Predictive of Response to Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Hepatocellular Carcinoma.
Study Start Date : October 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patient treated
patient who receive sunitinib
Drug: Sutent
Sunitinib 50mg/day (per os) for 6 cycles duration of one cycle = 6 weeks (4 weeks of treatment over 6 weeks)




Primary Outcome Measures :
  1. Objective response [ Time Frame: 1 year ]
    to evaluate the objective response according to RECIST Criteria 1.1


Secondary Outcome Measures :
  1. Objective response [ Time Frame: 1 year ]
    to evaluate objective response to sunitinib according to secondary radiological criteria (evaluation on CT scan of: tumor density, % of tumor necrosis and tumor vascularisation)

  2. Overall survival [ Time Frame: 6 months and 1 year ]
  3. Progression-Free survival [ Time Frame: 6 months and 1 year ]
  4. Biomarkers of response [ Time Frame: 1 year ]
    to evaluate the correlation between biomarkers expression and objective response so sunitinib

  5. Biomarkers of radiological response [ Time Frame: 1 year ]
    to evaluate the correlation between biomarkers expression and secondary radiological criteria (significant decrease of tumor density on CT scan, formation of significant intratumor necrosis, significant decrease of tumoral vascularisation using of perfusion software



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fibrolamellar hepatocellular carcinoma histopathologically proven
  • Inoperable/advanced (Tumor recurrence inoperable or metastatic with no surgical indication).
  • Available Tumor tissue for analysis(biopsy or surgical specimen)
  • Performance status WHO ≤ 2.
  • Adequate organ function :

    • Hematology (absolute neutrophil count equal or superior to 1,5 x 10*9/l , platelet equal or superior to 100 x 10*9/l),
    • clearance of creatinine > 60 ml/min),
    • AST/ALT ≤ 5 N, PAL ≤ 5 N, total bilirubin ≤ 2N.

Exclusion Criteria:

  • Hypersensitivity to sunitinib.
  • Contraindication to sunitinib, including uncontrolled hypertension, medical history of cerebrovascular accident, unstable cardiac pathology despite optimal medical therapy (myocardial infarction within the 6 months prior to study drug administration, severe/unstable angina ), active hemorrhagic syndrome or concomitant treatment with anticoagulants.
  • Any severe acute or chronic co-morbid that may compromise to comply with study participation : uncontrolled infection, symptomatic congestive heart failure, liver disturbance, chronic renal failure, active gastro-duodenal ulcer (nonexhaustive list)
  • Known brain metastases.
  • Diagnosis of any second malignancy within the last 3 years, except for basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri
  • Current treatment on another clinical trial.
  • Prior treatment with an investigational agent within 4 weeks
  • Patient on i.v bisphosphonate therapy

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): NCT01215565


Locations
Layout table for location information
France
Hôpital Beaujon
Clichy, Hauts de Seine, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Sandrine Faivre, Professor Assistance Publique - Hôpitaux de Paris

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01215565     History of Changes
Other Study ID Numbers: P070134
2008-003423-23 ( EudraCT Number )
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Carcinoma, Hepatocellular
Carcinoma
Fibrosis
Liver Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Liver Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sunitinib
Angiogenesis Modulating Agents
Antineoplastic Agents
Angiogenesis Inhibitors
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action