Sunitinib Before and After Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00747305|
Recruitment Status : Terminated (Study terminated early due to low accrual.)
First Posted : September 5, 2008
Last Update Posted : October 22, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||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||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomarkers of Tumor Angiogenesis and Response to Sunitinib Maleate in Renal Cell Carcinoma|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Sunitinib will be administered for 8 weeks prior to sugery
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
- Describe the gene expression of VEGF and non-VEGF from eligible patients being treatment with Sunitinib. [ Time Frame: at various points throughout the study duration ]
- Describe the association between quantitative gene expression levels of VEGF and non-VEGF angiogenic factors with the clinical efficacy of Sunitinib as measured by response, duration or response and time to progression [ Time Frame: at various points throughout the study duration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747305
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Harry A. Drabkin, MD||Medical University of South Carolina|