AZD2171 in Treating Patients With Progressive Locally Recurrent or Metastatic Kidney Cancer That Cannot Be Removed By Surgery
Recruitment status was Active, not recruiting
RATIONALE: AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying AZD2171 to see how well it works in treating patients with progressive locally recurrent or metastatic kidney cancer that cannot be removed by surgery.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of AZD2171 in Progressive Unresectable, Recurrent or Metastatic Renal Cell Carcinoma|
- Objective response rate and rate of stable disease ≥ 4 months [ Designated as safety issue: No ]
- Duration of response or stable disease [ Designated as safety issue: No ]
- Progression-free, median, and overall survival [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
- Correlation of levels of soluble markers of angiogenic growth factors and receptors and circulating endothelial cells with clinical outcome [ Designated as safety issue: No ]
- Correlation of changes in blood flow and vessel permeability with clinical outcome [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
- Determine the clinical benefit rate (objective response rate and rate of stable disease for ≥ 4 months) in patients with progressive unresectable, locally recurrent or metastatic renal cell carcinoma treated with AZD2171.
- Determine the duration of response or stable disease in patients treated with this drug.
- Determine progression-free, median, and overall survival of patients treated with this drug.
- Determine the safety and tolerability of this drug in these patients.
- Correlate levels of soluble markers of angiogenic growth factors and receptors and circulating endothelial cells with clinical outcome in patients treated with this drug.
- Correlate changes in blood flow and vessel permeability with clinical outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.
|Cross Cancer Institute at University of Alberta|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Hospital Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Srikala Sridhar, MD, FRCPC, MSC||Princess Margaret Hospital, Canada|