Sunitinib Before and After Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed By Surgery
Recruitment status was Recruiting
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying how well sunitinib works when given before and after surgery in treating patients with metastatic kidney cancer that can be removed by surgery.
Drug: sunitinib malate
Genetic: gene expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Genetic: western blotting
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Biomarkers of Tumor Angiogenesis and Response to Sunitinib Maleate in Renal Cell Carcinoma|
- Baseline gene expression of plasma biomarkers of tumor angiogenesis and response (i.e., VEGF and non-VEGF angiogenic growth factor genes) [ Designated as safety issue: No ]
- Post-treatment gene expression of plasma biomarkers of tumor angiogenesis and response as measured at 4 and 8 weeks [ Designated as safety issue: No ]
- Absolute change in gene expression of plasma biomarkers of tumor angiogenesis and response from baseline to 4 and 8 weeks [ Designated as safety issue: No ]
- Percentage change in gene expression of plasma biomarkers of tumor angiogenesis and response from baseline to 4 and 8 weeks [ Designated as safety issue: No ]
- Post-treatment gene expression of tumor biomarkers of tumor angiogenesis and response at 4 and 8 weeks [ Designated as safety issue: No ]
- Response (i.e., complete and partial response) as assessed by RECIST criteria [ Designated as safety issue: No ]
- Time to progression as assessed by RECIST criteria [ Designated as safety issue: No ]
- Duration of response (in patients who achieve response) [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
- To describe the gene expression of VEGF and non-VEGF angiogenic growth factor genes in kidney cancer specimens from patients with metastatic renal cell carcinoma treated with sunitinib malate.
- To describe the association between quantitative gene expression levels of VEGF and non-VEGF angiogenic factors and clinical efficacy of this drug, as measured by response, duration of response, and time to progression in these patients.
OUTLINE: Patients receive oral sunitinib malate once daily for 8 weeks. Within 2 weeks after completion of neoadjuvant chemotherapy, patients undergo a nephrectomy and evaluation for response to therapy. Beginning 4-8 weeks after surgery patients resume oral sunitinib malate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.
Patients with disease progression after 8 weeks of adjuvant treatment receive treatment off study with other agents.
Viable (non-necrotic) tumor and non-tumor kidney tissue samples are obtained at the time of nephrectomy for correlative biomarker studies. Tissue samples are analyzed for gene expression of VEGF and non-VEGF angiogenic factors by real-time RT-PCR, western blot, and/or IHC. Blood samples are obtained at baseline and at 4 and 8 weeks for evaluation of circulating levels of VEGF and selected chemokines.
After completion of study therapy, patients are followed monthly.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747305
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321|
|Principal Investigator:||Harry A. Drabkin, MD||Medical University of South Carolina|