A Phase 2 Study of AZD2171 in Progressive Unresectable, Recurrent or Metastatic Renal Cell Carcinoma
- 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
- Determine progression-free, median, and overall survival of patients treated with this
- 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
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12
Masking: Open Label, Primary Purpose: Treatment
Objective response rate and rate of stable disease ≥ 4 months
Srikala Sridhar, MD, FRCPC, MSC
Princess Margaret Hospital, Canada
United States: Federal Government