Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00459979 |
Recruitment Status
:
Completed
First Posted
: April 13, 2007
Results First Posted
: January 7, 2014
Last Update Posted
: March 7, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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 |
|
|||
Change History | Complete list of historical versions of study NCT00459979 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
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:
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 |
|
|||
Study Arms | Experimental: Sunitinib
Interventions:
|
|||
Publications * |
|
|||
* 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 |
30 | |||
Original Enrollment ICMJE |
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:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
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 |
|
|||
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 |