Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery
|ClinicalTrials.gov Identifier: NCT00459979|
Recruitment Status : Completed
First Posted : April 13, 2007
Results First Posted : January 7, 2014
Last Update Posted : March 7, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: sunitinib malate Procedure: conventional surgery||Phase 2|
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors|
|Study Start Date :||March 2007|
|Primary Completion Date :||March 2011|
|Study Completion Date :||September 2013|
Drug: sunitinib malate
Sunitinib will be dosed at 50 mg p.o. daily
Other Names:Procedure: conventional surgery
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459979
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Brian I. Rini, MD||Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center|