Sunitinib Before or After Surgery in Treating Patients With Metastatic Kidney Cancer
Recruitment status was Recruiting
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.
Drug: sunitinib malate
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma|
- Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Time to progression [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|Ospedale Sacro Cuore||Recruiting|
|Negrar, Italy, 37024|
|Contact: Contact Person 39-045-601-3912|
|Principal Investigator:||Marco Venturini, MD||Ospedale Sacro Cuore|