5366S-13: C80802 HCC

CTSU C80802: Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

Type of Study
Cancer (Oncology) - Liver
Swedish Cancer Institute
Short Description
Purpose: This randomized phase III trial is studying sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with locally advanced or metastatic liver cancer. Sorafenib tosylate 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. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than sorafenib tosylate alone in treating liver cancer.
Temporarily Closed
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • Patients must have locally advanced or metastatic disease; Locally advanced disease is defined as disease deemed to be unresectable or non-eligible for transplant without distant metastases
  • Lesions must be accurately measurable in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral CT scan
  • No prior adjuvant sorafenib or other Raf/VEGF inhibitors; Other prior adjuvant therapy is allowed if completed >6 months prior to registration with documented recurrence of HCC
  • Patients may have been treated with loco regional therapies provided that they either have:
    • a target lesion that has not been subjected to local therapy or
    • the target lesion(s) within the field of the local therapy has shown an increase of >= 20% in the size since last treatment.
  • Such therapy must be completed at least 4 weeks prior to registration; Patients that have received palliative radiation therapy to the bone need not wait 4 weeks to begin protocol therapy
  • Prior therapies allowed include the following:
    • bland embolization, radiation, radioactive microspheres, etc
    • chemoembolization using any chemotherapy (except, see "D", below)
    • chemoembolization drug-eluting beads using doxorubicin
    • prior therapy with chemoembolization using doxorubicin in the non drug eluting beads form is NOT allowed
  • No prior systemic therapy for metastatic disease
  • No prior exposure to systemic doxorubicin administered intravenously
  • ECOG performance status 0-1
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086