Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer

Conditions

• Liver Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — BIOLOGICAL
  Given IV
• sorafenib tosylate — DRUG
  Given orally

Study Details

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor. PURPOSE: This randomized phase I/II trial is studying the best dose of bevacizumab when given together with sorafenib as first-line therapy in treating patients with locally advanced or metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)

Key Dates

First listed

Mar 23, 2009

Start date

Apr 30, 2009

Status verified

Mar 2022

Primary completion

Apr 30, 2012

Completion

May 31, 2013

Study Design

Enrollment

24 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (Phase II)
  Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
• Experimental: Arm II (Phase II)
  Patients receive oral sorafenib tosylate twice daily on days 1-28.

Primary Outcome Measure

Maximum Tolerated Dose (Phase I) [ Time Frame: From baseline up to 3 years post treatment ]

Locations (177)

Find similar trials in Scottsdale, AZ

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