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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00876382
First received: April 3, 2009
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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
Renal Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: May 2009
Study Completion Date: August 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00876382     History of Changes
Other Study ID Numbers: SCRI OUTCOMES 06
Study First Received: April 3, 2009
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

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, Renal Cell
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014