Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma
Information source: Sarah Cannon Research Institute
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Renal Cell Carcinoma
Phase: N/A
Status: Not yet recruiting
Sponsored by: Sarah Cannon Research Institute Official(s) and/or principal investigator(s):
Jeffrey F Patton, M.D., Study Chair, Affiliation: SCRI Oncology Research Consortium
Overall contact:
Jeffrey F Patton, M.D., Phone: (615) 329-7274, Email: jpatton@tnonc.com
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)
Clinical Details
Official title: Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma
Study design: Case-Only, Retrospective
Primary outcome: 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.
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Jeffrey F Patton, M.D., Phone: (615) 329-7274, Email: jpatton@tnonc.com
Consultants in Blood Disorders and Cancer, Louisville, Kentucky 40207, United States
Oncology Hematology Care, Cincinnati, Ohio 45242, United States
Tennessee Oncology, PLLC, Nashville, Tennessee 37023, United States
Additional Information
Starting date: May 2009
Ending date: November 2010
Last updated: April 3, 2009
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