Sunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated Metastatic Kidney Cancer
|ClinicalTrials.gov Identifier: NCT01024205|
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : August 12, 2013
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving sunitinib malate before and after surgery works in treating patients with metastatic kidney cancer.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: sunitinib malate Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery||Phase 2|
- Determine if neoadjuvant sunitinib malate can achieve a clinical benefit of 70% or more to the primary renal tumor prior to surgery and adjuvant sunitinib malate in patients with metastatic renal cancer.
- Determine the time to radiological progression in these patients.
- Determine the overall survival of these patients.
- Determine the proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate.
- Determine the translational endpoints.
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for 3 courses. Approximately 2 weeks later, patients undergo a standard radical nephrectomy with lymph node dissection. Beginning at least 2 weeks after surgery, patients receive oral sunitinib malate on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Blood and tissue samples may be collected periodically for laboratory studies.
After completion of study treatment, patients are followed every 2 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Masking:||None (Open Label)|
|Official Title:||Upfront Sunitinib (SU011248) Therapy Followed by Surgery in Patients With Metastatic Renal Cancer: A Pilot Phase II Study [SuMR]|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||May 2012|
- Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%
- Time to radiological progression
- Overall survival
- Proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024205
|Orchid Clinical Trials Group at Barts and the London School of Medicine and Dentistry|
|London, England, United Kingdom, EC1M 6BQ|
|Principal Investigator:||Thomas Powles, MD, MRCP||Barts and the London School of Medicine and Dentistry|