Kidney Cancer Clinical Trial
Official title:
Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Sunitinib 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 before
surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
removed. Giving it after surgery may kill any tumor cells that remain after surgery. It is
not yet known whether sunitinib is more effective when given before or after surgery in
treating kidney cancer.
PURPOSE: This randomized phase II trial is studying the side effects of sunitinib and to
compare how well it works when given before or after surgery in treating patients with
metastatic kidney cancer.
OBJECTIVES:
Primary
- To compare the activity of sunitinib malate when administered before vs after
cytoreductive nephrectomy, in terms of response rate, in patients with metastatic renal
cell carcinoma.
- To compare the safety of these regimens in these patients.
Secondary
- To compare the time to progression in patients treated with these regimens.
- To compare the duration of response in patients treated with these regimens.
- To compare the overall survival of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo cytoreductive nephrectomy. Patients then receive adjuvant
therapy comprising oral sunitinib malate once daily for 4 weeks. Treatment repeats
every 6 weeks for up to 1 year in the absence of disease progression or unacceptable
toxicity. Some patients may continue treatment beyond 1 year at the discretion of the
investigator.
- Arm II: Patients receive neoadjuvant therapy comprising oral sunitinib malate once
daily for 4 weeks. Treatment repeats every 6 weeks for 2 courses. After completion of
neoadjuvant therapy, patients undergo cytoreductive nephrectomy followed by adjuvant
sunitinib malate as in arm I.
After completion of study therapy, patients are followed every 2 months for up to 1 year.
;
Allocation: Randomized, Primary Purpose: Treatment
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