Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating patients with previously untreated metastatic kidney cancer.
Clear Cell Renal Cell Carcinoma
Stage IV Renal Cell Cancer
Drug: sunitinib malate
Other: laboratory biomarker analysis
Genetic: reverse transcriptase-polymerase chain reaction
Genetic: polymorphism analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Intermittent Sunitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma|
- Feasibility as assessed by proportion of patients eligible for intermittent therapy who actually receive it [ Time Frame: after 6 months of treatment (4 cycles) ] [ Designated as safety issue: No ]Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
- Toxicity as assessed by Common Terminology Criteria for Adverse Events(CTCAE) version 4.0 [ Time Frame: after 6 months of treatment (4 cycles) ] [ Designated as safety issue: Yes ]
- Change in circulating tumor cells [ Time Frame: Pre-treatment, day 1, and day 28 of every cycle ] [ Designated as safety issue: No ]
- Relationship between hypertension and germline VEGF single nucleotide polymorphism (SNP) -634 genotype [ Time Frame: Day 28 of each cycle ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: sunitinib malate
Other Names:Other: laboratory biomarker analysis
Correlative studiesGenetic: reverse transcriptase-polymerase chain reaction
Other Name: RT-PCRGenetic: polymorphism analysis
I. To determine the feasibility of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma (RCC).
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158222
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Brian Rini||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|