Cediranib Maleate in Treating Patients With Recurrent or Metastatic Kidney Cancer That Cannot Be Removed By Surgery
This phase II trial studies how well cediranib maleate works in treating patients with recurrent or metastatic kidney cancer that cannot be removed by surgery. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Drug: cediranib maleate
Other: laboratory biomarker analysis
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Other: pharmacological study
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of AZD2171 in Progressive Unresectable, Recurrent or Metastatic Renal Cell Carcinoma (RCC)|
- Incidence of durable stable disease, evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Objective response, evaluated using RECIST [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: Time from start of treatment to progression, death or last contact, or last tumor assessment before the start of further antitumor therapy, assessed up to 6.5 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Estimated Primary Completion Date:||January 2100 (Final data collection date for primary outcome measure)|
Experimental: Treatment (cediranib maleate)
Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: cediranib maleate
Other Names:Other: laboratory biomarker analysis
Correlative studiesProcedure: dynamic contrast-enhanced magnetic resonance imaging
Other Name: DCE-MRIOther: pharmacological study
Other Name: pharmacological studies
I. To assess the clinical benefit rate (objective response rate and rate of stable disease for at least 4 months) of AZD2171 (cediranib maleate) given to patients with progressive unresectable or, recurrent or metastatic renal cell carcinoma (RCC).
II. To assess the duration of response or stable disease, progression free, median and overall survival rates, and safety and tolerability of AZD2171.
III. To measure baseline and post treatment levels of soluble markers of angiogenic growth factors and receptors as well as levels of circulating endothelial cells, and correlate these with clinical outcome.
IV. To assess changes in blood flow and vessel permeability using dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) pre and post treatment and to correlate these changes with clinical outcome.
Patients receive cediranib maleate orally (PO) once daily (QD) 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 up at 4 weeks and then every 3 months thereafter.
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA-Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus|
|Ottawa, Ontario, Canada, K1Y 4E9|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Srikala Sridhar||Princess Margaret Hospital Phase 2 Consortium|