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Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma


N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Renal Cell Carcinoma

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Trial Information

Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma


Recently, a number of targeted agents have demonstrated single-agent activity in the
treatment of advanced renal cell carcinoma. Bevacizumab, a humanized monoclonal antibody
directed against VEGF, resulted in an improvement in median progression-free survival when
compared to placebo in a prospective, randomized trial. More recently, the multitargeted
agents sorafenib and sunitinib have been approved for use in the treatment of advanced renal
cell carcinoma. Both have proven superior to previous interferon and other standard
treatment; however it is not clear how these drugs should be used in the treatment sequence.
With roughly 80% of cancer patients receiving their oncology care in the community setting,
we are proposing a review and evaluation of at least 200 advanced renal cell carcinoma
patients.


Inclusion Criteria:



- Eligible patient cases are those that have received Sorafenib (Nexavar) as
second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line
therapy or those patients that were treated with Sorafenib (Nexavar) as first-line
therapy followed by Sunitinib (Sutent) as secondline therapy.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

To evaluate the safety and efficacy of Nexavar as second-line therapy in patients with advanced renal cell carcinoma treated with Nexavar after first-line therapy with Sutent or Avastin.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Jeffrey F Patton, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI OUTCOMES 06

NCT ID:

NCT00876382

Start Date:

May 2009

Completion Date:

November 2012

Related Keywords:

  • Advanced Renal Cell Carcinoma
  • advanced renal cell carcinoma
  • renal cancer
  • renal cell
  • Sorafenib
  • Nexavar
  • Bevacizumab
  • Avastin
  • Sunitinib
  • Sutent
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location
Northeast Arkansas Clinic Jonesboro, Arkansas  72401-3125
Consultants in Blood Disorders and Cancer Louisville, Kentucky  40207
Medical Oncology Associates of Augusta Augusta, Georgia  30901
Gulfcoast Oncology Associates St. Petersburg, Florida  33705
St. Louis Cancer Care Chesterfield, Missouri  63017
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Jackson Oncology Associates Jackson, Mississippi  39202
Oncology Hematology Care Cincinnati, Ohio  45242