Cediranib Maleate in Treating Patients With Recurrent or Metastatic Kidney Cancer That Cannot Be Removed By Surgery
|ClinicalTrials.gov Identifier: NCT00227760|
Recruitment Status : Completed
First Posted : September 28, 2005
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Renal Cell Carcinoma Stage IV Renal Cell Cancer||Drug: Cediranib Maleate Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of AZD2171 in Progressive Unresectable, Recurrent or Metastatic Renal Cell Carcinoma (RCC)|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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:Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
- Incidence of Durable Stable Disease, Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 4 weeks ]Stable disease for a clinical benefit rate, evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)
- Objective Response, Evaluated Using RECIST [ Time Frame: 4 weeks ]Partial response as assessed by RECIST criteria
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227760
|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||University Health Network Princess Margaret Cancer Center P2C|