Upfront Sunitinib (SU011248) Therapy Followed by Surgery in Patients With Metastatic Renal Cancer: A Pilot Phase II Study [SuMR]
- 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
- 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
Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%
Thomas Powles, MD, MRCP
Orchid Clinical Trials Group at Barts and the London School of Medicine and Dentistry