A Phase II Study of Intermittent Sunitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma
PRIMARY OBJECTIVES:
I. To determine the feasibility of intermittent sunitinib therapy in patients with
metastatic renal cell carcinoma (RCC).
SECONDARY OBJECTIVES:
I. To determine the clinical outcome (response rate and overall progression-free survival)
in metastatic renal cell carcinoma patients treated with intermittent sunitinib therapy.
II. To evaluate the toxicity of intermittent sunitinib therapy in patients with metastatic
renal cell carcinoma.
III. To assess the feasibility of detecting circulating tumor cells (CTCs) in RCC patients
and investigate the association between the VEGF -634 genotype and the occurrence of
hypertension in sunitinib-treated RCC patients.
OUTLINE:
Patients receive oral sunitinib malate once daily on days 1-28. Sunitinib dosing schedule
may be changed to 14 days on followed by 7 days off, and repeated for a 6-week cycle, at the
discretion of the treating physician for toxicity purposes. Cycles will be defined as 6 week
intervals regardless of dosing interruptions. All patients will be treated for 4 cycles in
the absence of unacceptable toxicity or RECIST-defined progressive disease.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility as assessed by proportion of patients eligible for intermittent therapy who actually receive it
Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
No
Brian Rini
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Institutional Review Board
CASE8809
NCT01158222
August 2010
Name | Location |
---|---|
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |