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

Sponsors and Collaborators:	Sarah Cannon Research Institute SCRI Oncology Research Consortium Bayer Onyx
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00876382

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
Advanced Renal Cell Carcinoma

MedlinePlus related topics: Cancer

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

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

Further study details as provided by Sarah Cannon Research Institute:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	May 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	May 2010 (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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876382

Contacts

Contact: Jeffrey F Patton, M.D.	(615) 329-7274	jpatton@tnonc.com
Contact: Trials Info	(615) 329-7274	trialsinfo@scresearch.net

Locations

United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
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

Sarah Cannon Research Institute

SCRI Oncology Research Consortium

Bayer Onyx

Investigators

Study Chair:

Jeffrey F Patton, M.D.

SCRI Oncology Research Consortium

More Information

No publications provided

Responsible Party:	SCRI Oncology Research Consortium ( Jeffrey F Patton, M.D. )
Study ID Numbers:	SCRI OUTCOMES 06
Study First Received:	April 3, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00876382 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sarah Cannon Research Institute:

advanced renal cell carcinoma
renal cancer
renal cell
Sorafenib
Nexavar

Bevacizumab
Avastin
Sunitinib
Sutent

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Urogenital Neoplasms
Bevacizumab
Urologic Neoplasms
Protein Kinase Inhibitors
Carcinoma
Renal Cancer

Urologic Diseases
Kidney Neoplasms
Sunitinib
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009