Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery

Tracking Information
First Submitted Date ICMJE	April 11, 2007
First Posted Date ICMJE	April 13, 2007
Results First Submitted Date	November 19, 2013
Results First Posted Date	January 7, 2014
Last Update Posted Date	March 7, 2014
Study Start Date ICMJE	March 2007
Actual Primary Completion Date	March 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 12, 2012)	Response to Sunitinib Therapy [ Time Frame: 1 year from start of treatment ]; Defined as a reduction in tumor burden to such an extent that nephrectomy is permitted within 1 year of the start of therapy. No response to sunitinib therapy is defined as a nephrectomy not being permitted within 1 year of the start of therapy or removal from the study for any reason
Original Primary Outcome Measures ICMJE; (submitted: April 11, 2007)	1-year event-free survival; Objective response (complete response and partial response)
Change History	Complete list of historical versions of study NCT00459979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 19, 2013)	The Number of Patients With Any Type of Complication or Adverse Event [ Time Frame: 1 year from start of treatment ]The safety of sunitinib will be assessed by recording the number of patients with any type of complication or adverse event within 1 year of the start of therapy.; Progression Free Survival [ Time Frame: 1 year from start of treatment ]Progression free survival is defined as the amount of time (in months) between the start of treatment and documented RECIST defined progression. RECIST progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition to an absolute increase of at least 5mm.; Percent Decrease of Diameter of Primary Tumors [ Time Frame: 1 year from start of treatment ]Median percent decrease in size in all primary renal cell carcinoma tumors. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.; Number of Tumors Which Decreased in Size [ Time Frame: 1 year from start of treatment ]Number of tumors with at least some reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.; Number of Tumors With 30% Reduction in Size [ Time Frame: 1 year from start of treatment ]Number of tumors with at least 30% reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.; Median Size Reduction Among Tumors With Some Shrinkage [ Time Frame: 1 year from start of treatment ]The median size reduction in the largest diameter of the primary RCC tumor among the tumors with at least some shrinkage in diameter
Original Secondary Outcome Measures ICMJE; (submitted: April 11, 2007)	Response
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery
Official Title ICMJE	A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors
Brief Summary	RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in treating patients with kidney cancer that cannot be removed by surgery.
Detailed Description	OBJECTIVES: To determine the percentage of patients with renal cell carcinoma and unresectable primary tumors who can achieve sufficient tumor response, according to the operating surgeon, to undergo nephrectomy after sunitinib therapy.; To evaluate the safety of sunitinib in patients with renal cell carcinoma and unresectable primary tumors, including analysis of the morbidity of surgery after sunitinib therapy; To evaluate the objective response rate of patients with renal cell carcinoma and unresectable primary tumors who receive sunitinib therapy. OUTLINE: A single arm phase II study of sunitinib in patients with unresectable renal cell carcinoma (RCC) will be conducted, including patients with and without distant metastases. Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. Surgery is performed if and when primary tumor becomes resectable. Patients with residual and/or metastatic disease may resume sunitinib malate within 8 weeks after surgery. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Kidney Cancer
Intervention ICMJE	Drug: sunitinib malate Sunitinib will be dosed at 50 mg p.o. daily Other Names: SUNITINIB L-Malate salt SU010398 PHA-290940AD Sutent SUNITINIB; Procedure: conventional surgery nephrectomy
Study Arms	Experimental: Sunitinib; Interventions: Drug: sunitinib malate; Procedure: conventional surgery
Publications *	Lane BR, Derweesh IH, Kim HL, O'Malley R, Klink J, Ercole CE, Palazzi KL, Thomas AA, Rini BI, Campbell SC. Presurgical sunitinib reduces tumor size and may facilitate partial nephrectomy in patients with renal cell carcinoma. Urol Oncol. 2015 Mar;33(3):112.e15-21. doi: 10.1016/j.urolonc.2014.11.009. Epub 2014 Dec 19.; Rini BI, Garcia J, Elson P, Wood L, Shah S, Stephenson A, Salem M, Gong M, Fergany A, Rabets J, Kaouk J, Krishnamurthi V, Klein E, Dreicer R, Campbell S. The effect of sunitinib on primary renal cell carcinoma and facilitation of subsequent surgery. J Urol. 2012 May;187(5):1548-54. doi: 10.1016/j.juro.2011.12.075. Epub 2012 Mar 14.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 20, 2011)	30
Original Enrollment ICMJE; (submitted: April 11, 2007)	62
Actual Study Completion Date	September 2013
Actual Primary Completion Date	March 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Histologically or cytologically confirmed renal cell carcinoma (any histology) based on prior biopsy or biopsy performed and reviewed at Cleveland Clinic Foundation. This can include pathology read as adenocarcinoma consistent with renal origin.; Unresectable primary tumor due to any of the following factors or various combinations thereof: Large tumor size (> 15 cm) Bulky lymphadenopathy (> 4 cm or encasement of renal vessels or great vessels) Venous thrombosis (high level/invasive disease requiring inferior vena cava reconstruction or hypothermic circulatory arrest) Proximity to vital structures (e.g., mesenteric vasculature) Any one of these factors may or may not constitute unresectability, but for consideration for this trial, the surgical and medical oncologist must agree that the particular constellation of findings for the patient under consideration would likely entail a low probability (<50%) that the tumor would be resectable (with negative margins) or that the potential morbidity associated with an attempt at surgical resection would not be clinically acceptable. The numerical thresholds noted above are only a guideline and the clinical judgment of the surgeon and medical oncologist will determine unresectability.; Patients with history of brain metastases can be enrolled 2 weeks following the completion of gamma knife or whole brain radiotherapy.; ECOG performance status (PS) 0-1 or Karnofsky PS >/=70%; Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 times upper limit of normal (ULN); Total Serum Bilirubin ≤ 1.5 times ULN; Absolute neutrophil count ≥ 1,500/mm³; Platelet count ≥ 100,000/mm³; Hemoglobin ≥ 8.0 g/dL (transfusion allowed); Serum calcium ≤ 12.0 mg/dL; Creatinine ≤ 2.5 mg/dL; Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment; Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: The presence of any of the following will exclude a patient from study enrollment:; Prior systemic treatment for RCC.; Evidence of bleeding diathesis or coagulopathy. Patients with hematuria from the primary renal tumor are eligible provided all other eligibility criteria are met.; Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism.; Hypertension that cannot be controlled by medications to < 160/90 mmHg.; Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.; Pregnancy or breastfeeding.; Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00459979
Other Study ID Numbers ICMJE	CASE17806; P30CA043703 ( U.S. NIH Grant/Contract ); CASE-17806 ( Other Identifier: Case Comprehensive Cancer Center ); CASE-17806-CC209 ( Other Identifier: Cancer Center IRB )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Case Comprehensive Cancer Center
Study Sponsor ICMJE	Case Comprehensive Cancer Center
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Study Chair: Brian I. Rini, MD Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
PRS Account	Case Comprehensive Cancer Center
Verification Date	February 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP