Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma RCC Votrient Pazopanib Nephrectomy Neoadjuvant Phase II LCCC 1028 Lineberger Comprehensive Cancer Center
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: no

Brief summary:
This study will be a single arm phase II clinical trial of 8 weeks of daily, oral neo-adjuvant pazopanib prior to nephrectomy in 39 evaluable patients with histologically confirmed localized renal cell carcinoma (RCC).

Detailed description:
The primary objective of this study is to determine the objective response rate Complete Response + Partial Response(CR+PR) associated with neoadjuvant pazopanib at 8 weeks as defined via Response Evaluation Criteria in Solid Tumors (RECIST1.1). The investigators will also estimate the recurrence free survival (RFS), specifically the 1 and 2 year rates, with recurrence defined via RECIST1.1, and characterize the safety issues. Finally, this study also includes a number of exploratory analyses designed to evaluate potential correlations between RFS and; serum levels of cytokine and angiogenesis factor (CAF).

Arms:
arm 1: Pazopanib 800 mg PO once daily for 8 weeks

Interventions: intervention 1: Pazopanib
Intervention descriptions: intervention 1: 800 mg orally once daily for 8 weeks, prior to nephrectomy

Protocol document: