Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and
      keeping anticancer drugs near the tumor. Sunitinib malate 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. It is not yet known whether chemoembolization is more effective with or without
      sunitinib malate in treating patients with liver cancer.

      PURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization
      of the liver and to see how well in works when given together with or without sunitinib
      malate in treating patients with liver cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate unacceptable bleeding or hepatic failure at 10 weeks post-treatment in
           patients with unresectable hepatocellular carcinoma treated with transarterial
           chemoembolization in combination with sunitinib malate versus transarterial
           chemoembolization alone.

        -  To evaluate the overall survival of these patients.

      Secondary

        -  To evaluate the tumor stabilization rate in these patients.

        -  To evaluate the safety of this regimen in these patients.

        -  To evaluate the disease-free survival of these patients.

        -  To evaluate the relapse-free survival of these patients.

        -  To evaluate the quality of life of these patients.

        -  To evaluate the overall survival rate at 2 years of these patients.

      OUTLINE: This is a multicenter study.

      Pilot: Patients receive oral sunitinib malate once daily on days 1-28. Beginning 7-10 days
      later, patients undergo 1-3 courses of transarterial chemoembolization (TACE). Treatment
      repeats every 6 weeks for 1 year.

      Randomization: Patients are stratified according to main tumor diameter (< 5 cm vs ≥ 5 cm),
      nodular involvement (uninodular vs multinodular), and center. Patients are randomized to 1 of
      2 treatment arms.

        -  Arm I: Patients receive sunitinib malate and TACE as in the pilot phase.

        -  Arm II: Patients receive oral placebo once daily on days 1-28 and TACE as in the pilot
           phase.

      Quality of life is assessed periodically.
    

Intervention name(s): sunitinib malate; Placebo; transarterial chemoembolization
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): placebo 3cps/days 4 weeks over 6 during 1 year; placebo 3cps/days 4 weeks over 6 during 1 year; Chimioembolisation
Intervention MeSH terms: Sunitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer; advanced adult primary liver cancer