Sorafenib in Treating Patients Undergoing Surgery for Stage II, Stage III, or Stage IV Kidney Cancer
- Registration Number
- NCT00405366
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Study sorafenib tosylate -
- Primary Outcome Measures
Name Time Method Number of subjects experiencing adverse events while taking sorafenib prior to nephrectomy 8 weeks Adverse events will be assessed (graded) using CTCAE criteria
Feasibility of neoadjuvant systemic therapy prior to nephrectomy 8 weeks Feasibility will be measured by the proportion of patients who complete therapy
- Secondary Outcome Measures
Name Time Method Response in primary renal tumors 8 weeks All patients will undergo pre and post-treatment tumor imaging by CT or MRI. Measurement of the primary tumor, and up to three largest index lesions for patients with metastatic disease, will be recorded on the case report form. The overall percentage of change in the sum of greatest dimension(s) of the kidney lesion (and three largest index lesions, if any) will be recorded. Response to therapy will be measured in absolute size change, as well as according to traditional RECIST criteria.
Effects of sorafenib tosylate therapy on gene expression, protein expression, and metabolic profile 8 weeks Microarray data will be done using statistical analysis and hierarchical clustering with the assistance of the UNC Genomics and Bioinformatics Core Facility
Trial Locations
- Locations (1)
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States