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

Sponsor

SCRI Development Innovations, LLC (Other)

Overall Status

Completed

CT.gov ID

NCT00876382

Collaborator

Bayer (Industry)

Enrollment

Locations

Duration (Months)

5.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

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 1, 2009

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Outcome Measures

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. [6 months]

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. [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Northeast Arkansas Clinic	Jonesboro	Arkansas	United States	72401
2	Gulfcoast Oncology Associates	St. Petersburg	Florida	United States	33705
3	Medical Oncology Associates of Augusta	Augusta	Georgia	United States	30901
4	Consultants in Blood Disorders and Cancer	Louisville	Kentucky	United States	40207
5	Jackson Oncology Associates	Jackson	Mississippi	United States	39202
6	St. Louis Cancer Care	Chesterfield	Missouri	United States	63017
7	Oncology Hematology Care	Cincinnati	Ohio	United States	45242
8	Tennessee Oncology, PLLC	Nashville	Tennessee	United States	37023