Tivozanib Before Surgery in Treating Patients With Localized Kidney Cancer
Stage II Renal Cell Cancer
Stage III Renal Cell Cancer
Procedure: therapeutic conventional surgery
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Clinical Trial of Neoadjuvant Tivozanib in Localized Renal Cell Carcinoma|
- Feasibility of conducting a trial of tivozanib in terms of patients completing 2 courses of tivozanib [ Time Frame: Up to 30 days after surgery ] [ Designated as safety issue: No ]
- Short-term efficacy defined as a composite of presence of partial response/stable disease/complete response assessed radiographically and correlated with the nephrectomy specimen per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: Up to 30 days after surgery ] [ Designated as safety issue: No ]Response rate will be examined using the sample proportion and corresponding 95% confidence interval.
- Incidence of adverse events evaluated using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days after surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2013|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (tivozanib and surgery)
Patients receive tivozanib PO QD on days 1-21. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. 25 days after completion of tivozanib, patients undergo curative nephrectomy.
Other Names:Procedure: therapeutic conventional surgery
I. To assess the feasibility of conducting a trial of tivozanib in the neoadjuvant setting of localized (completely resectable) renal cell cancer (RCC).
I. To evaluate the safety of tivozanib in the neoadjuvant setting. II. To compare the tissue before and after tivozanib for pharmacodynamic purposes (tumor infiltrating lymphocytes, myeloid derived suppressor cells, necrosis in the primary tumor after exposure to tivozanib).
III. To assess the overall response rate of tivozanib in primary tumors and correlate the radiographic changes, if any, to histo-pathological changes in the pathology specimen post-nephrectomy.
IV. To compare the various growth factors (vascular endothelial growth factor [VEGF], interleukin-8 [IL-8], placenta growth factor [P1GF]) at baseline and post treatment.
V. To assess the nephrectomy rate after applying neoadjuvant tivozanib in this primarily resectable RCC population.
Patients receive tivozanib orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. 25 days after completion of tivozanib, patients undergo curative nephrectomy.
After completion of study treatment, patients are followed up at 30 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769885
|Principal Investigator:||Saby George||Roswell Park Cancer Institute|