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AZD2171 in Treating Patients With Refractory Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00303862
Recruitment Status : Terminated
First Posted : March 17, 2006
Results First Posted : November 20, 2013
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions Drug: cediranib maleate
Other: laboratory biomarker analysis
Enrollment 10
Recruitment Details Patients were enrolled between December, 2006 and July, 2007 at three institutions. The trial was terminated after 10 patients were enrolled due to insufficent accrual rate.
Pre-assignment Details  
Arm/Group Title Treatment (Cediranib Maleate)
Hide Arm/Group Description Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Treatment (Cediranib Maleate)
Hide Arm/Group Description Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  60.0%
>=65 years
4
  40.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
63.8  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
3
  30.0%
Male
7
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Objective Response
Hide Description Objective radiologic response as measured by RECIST criteria. (30% or greater shrinkage in the sum of the longest diameters of target lesions)
Time Frame Up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Cediranib Maleate)
Hide Arm/Group Description:
Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20
(2.5 to 55.6)
2.Secondary Outcome
Title Performance of DCE_MRI
Hide Description Binary (yes/no) indicator of whether a dynamic contrast-enhanced MRI (DCE-MRI)was successfully performed.
Time Frame One month after initiating therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Because trial was closed due to poor accrual, MRI data were not collected.
Arm/Group Title Treatment (Cediranib Maleate)
Hide Arm/Group Description:
Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title KDR
Hide Description Kinase insert domain-containing vascular endothelial growth factor receptor
Time Frame Day 28 after initiation of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Because trial was closed due to poor accrual, assays were not performed.
Arm/Group Title Treatment (Cediranib Maleate)
Hide Arm/Group Description:
Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title eNOS
Hide Description Endothelial nitric oxide synthase gene (eNOS). Record genotype=number of minor alleles.
Time Frame Baseline (prior to therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
Because trial was closed due to poor accrual, assays were not performed.
Arm/Group Title Treatment (Cediranib Maleate)
Hide Arm/Group Description:
Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Grade 2 or higher
 
Arm/Group Title Treatment (Cediranib Maleate)
Hide Arm/Group Description Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Cediranib Maleate)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Cediranib Maleate)
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Cediranib Maleate)
Affected / at Risk (%)
Total   10/10 (100.00%) 
Cardiac disorders   
Hypertension *  7/10 (70.00%) 
Ear and labyrinth disorders   
Ear, nose, and throat exam abnormal *  2/10 (20.00%) 
Endocrine disorders   
Hyperglycemia *  1/10 (10.00%) 
Hyperthyroidism *  1/10 (10.00%) 
Hypothyroidism *  3/10 (30.00%) 
Gastrointestinal disorders   
Abdominal pain *  2/10 (20.00%) 
Anorexia *  1/10 (10.00%) 
Diarrhea *  4/10 (40.00%) 
Flatulence *  1/10 (10.00%) 
Gastritis *  1/10 (10.00%) 
Nausea/vomiting *  1/10 (10.00%) 
General disorders   
Fatigue *  4/10 (40.00%) 
Hand-and-foot syndrome *  5/10 (50.00%) 
Prostatic pain *  1/10 (10.00%) 
Infections and infestations   
Infection *  1/10 (10.00%) 
Upper respiratory infection *  1/10 (10.00%) 
Metabolism and nutrition disorders   
Alanine aminotransferase increased *  1/10 (10.00%) 
Alkaline phosphatase increased *  1/10 (10.00%) 
Creatinine increased *  1/10 (10.00%) 
Hypoalbuminemia *  1/10 (10.00%) 
Hypocalcemia *  1/10 (10.00%) 
Hypophophatemia *  1/10 (10.00%) 
Proteinuria *  3/10 (30.00%) 
Musculoskeletal and connective tissue disorders   
Back pain *  1/10 (10.00%) 
Bone pain *  1/10 (10.00%) 
Muscle weakness *  1/10 (10.00%) 
Nervous system disorders   
Neurological disorder NOS *  1/10 (10.00%) 
Seizure *  1/10 (10.00%) 
Psychiatric disorders   
Anxiety *  1/10 (10.00%) 
Reproductive system and breast disorders   
GU bleeding *  1/10 (10.00%) 
Urogenital disorder *  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough *  1/10 (10.00%) 
Respiratory disorder *  1/10 (10.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Theodore Karrison, PhD
Organization: University of Chicago
Phone: 773-702-9326
EMail: tkarrison@health.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00303862     History of Changes
Other Study ID Numbers: NCI-2012-02686
NCI-2012-02686 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000460237
UCCRC-NCI-7111
NCI-7111
14018A ( Other Identifier: University of Chicago )
7111 ( Other Identifier: CTEP )
P30CA014599 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
First Submitted: March 15, 2006
First Posted: March 17, 2006
Results First Submitted: July 8, 2013
Results First Posted: November 20, 2013
Last Update Posted: May 21, 2014