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

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ClinicalTrials.gov Identifier: NCT00876382
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : November 14, 2013
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Brief Summary:

A retrospective medical record abstraction study of at least 200 advanced renal cell carcinoma patients treated in the following settings:

  • Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line therapy (about 100 patients)
  • Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as first-line therapy followed by Sunitinib (Sutent) as second-line therapy (about 100 patients)

Condition or disease
Renal Cell Carcinoma

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma
Study Start Date : May 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. To evaluate safety and efficacy of Nexavar as first-line therapy in patients with advanced renal cell carcinoma and as first-line therapy followed by Sutent as second-line therapy in patients with advanced renal cell carcinoma. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Two hundred plus patients treated with Nexavar as first or second line therapy for advanced renal cell carcinoma.
Criteria

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.

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): NCT00876382


Locations
United States, Arkansas
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
United States, Florida
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States, 33705
United States, Georgia
Medical Oncology Associates of Augusta
Augusta, Georgia, United States, 30901
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Mississippi
Jackson Oncology Associates
Jackson, Mississippi, United States, 39202
United States, Missouri
St. Louis Cancer Care
Chesterfield, Missouri, United States, 63017
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Bayer
Investigators
Study Chair: Jeffrey F Patton, M.D. SCRI Development Innovations, LLC

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00876382     History of Changes
Other Study ID Numbers: SCRI OUTCOMES 06
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013

Keywords provided by SCRI Development Innovations, LLC:
advanced renal cell carcinoma
renal cancer
renal cell
Sorafenib
Nexavar
Bevacizumab
Avastin
Sunitinib
Sutent

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action