NCT00405366

Sorafenib in Treating Patients Undergoing Surgery for Stage II, Stage III, or Stage IV Kidney Cancer

A Pilot Neoadjuvant Clinical Trial With Evaluation of Molecular Effects With Sorafenib Tosylate for Patients With Stage II or Greater Renal Cell Carcinoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Sorafenib 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 sorafenib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying the side effects and how well sorafenib works in treating patients undergoing surgery for stage II, stage III, or stage IV kidney cancer.

Detailed description

OBJECTIVES: Primary * Determine the safety and feasibility of systemic sorafenib tosylate therapy when given prior to definitive nephrectomy in patients with stage II-IV renal cell carcinoma (RCC). Secondary * Determine all levels of response in primary renal tumors of patients treated with this drug. * Assess effects of this drug on gene expression, protein expression, and metabolic profile using tumor tissue samples from these patients. * Identify biomarkers or biomarker patterns associated with RCC or this drug in these patients. OUTLINE: This is a pilot, open-label, nonrandomized study. Patients receive oral sorafenib tosylate twice daily for 4-8 weeks in the absence of disease progression or unacceptable toxicity. After completion of neoadjuvant therapy, patients undergo surgical resection of their kidney tumor. Patients undergo blood and urine sample collection at baseline and after completion of treatment (i.e., at 4 and 8\* weeks) for VEGF analysis. Samples are examined by enzyme-linked immunosorbent assay for measurement of serum and urinary VEGF levels. NOTE: \*Blood sampling at 8 weeks is only for those patients undergoing 8 weeks of study therapy. Patients also undergo tissue sample collection at the time of nephrectomy. Tissue samples are examined by microarray analysis and IHC staining for expression of CD31/PECAM, HIF1α, and HIF2α. Immunohistochemical staining to identify biomarkers of microvessel density is also performed. Tissue samples are also examined for gene expression and metabolic profile by small molecule mass spectroscopy, as well as VHL gene mutation by VHL mutation analysis. Patients are followed at 4-8 weeks after nephrectomy.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Patients will receive treatment with 400mg of sorafenib, orally, twice daily, on a continuous basis as a single agent for at least 4 weeks, but not more than 8 weeks prior to their scheduled nephrectomy

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-06-01
• Completion: 2015-07-01
• First posted: 2006-11-30
• Last updated: 2017-04-18

Locations

1 site across 1 country: United States