Kidney Cancer Clinical Trial
Official title:
Upfront Sunitinib (SU011248) Therapy Followed by Surgery in Patients With Metastatic Renal Cancer: A Pilot Phase II Study [SuMR]
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
;
Masking: Open Label, Primary Purpose: Treatment
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