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Pazopanib in Treating Patients With Metastatic Urothelial Cancer

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ClinicalTrials.gov Identifier: NCT00471536
Recruitment Status : Completed
First Posted : May 10, 2007
Results First Posted : March 21, 2013
Last Update Posted : May 30, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Distal Urethral Cancer
Proximal Urethral Cancer
Recurrent Bladder Cancer
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
Recurrent Urethral Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Urethral Cancer Associated With Invasive Bladder Cancer
Intervention Drug: pazopanib hydrochloride
Enrollment 19
Recruitment Details Nineteen participants were accrued between October 2008 and December 2009.
Pre-assignment Details Of the 19 participants accrued, one participant canceled prior to treatment evaluation, and therefore was excluded from toxicity analysis. This participant was included in the primary endpoint analysis.
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 19
Completed 18
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
66
(42 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
5
  26.3%
Male
14
  73.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
United States 14
Korea, Republic of 1
Hong Kong 2
Australia 2
1.Primary Outcome
Title Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST])
Hide Description

Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria:

A Complete Response (CR) requires the disappearance of all target lesions.

A Partial Response (PR) requires >=30% decrease in the sum of the longest diameter of target lesions from baseline measurement.

All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.

Time Frame Participants will be evaluated every 8 weeks during treatment and up to 1 year after completion of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluated for response.
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description:
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
Partial Response (PR) 0
Complete Response (CR) 0
2.Secondary Outcome
Title Adverse Events Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Hide Description The maximum grade for each adverse event considered to be at least possibly related to treatment will be recorded. Frequency tables will be constructed.
Time Frame Every 4 weeks during treatment (maximum duration was 44 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Eighteen of the 19 participants accrued to the study were evaluable for adverse events.
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description:
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
Grade 3 Adverse Events 7
Grade 4 or Higher Adverse Events 0
3.Secondary Outcome
Title Confirmed Tumor Response (CR and PR)
Hide Description Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. A confirmed response is defined as a CR or PR and is documented on 2 consecutive evaluations.
Time Frame Documented on 2 consecutive evaluations 8 weeks apart from the start of the treatment until disease progression/recurrence, assessed up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description:
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
Confirmed Partial Response (PR) 0
Confirmed Complete Response (CR) 0
4.Secondary Outcome
Title Duration of Response
Hide Description The distribution of response durations will be estimated using the Kaplan-Meier method.
Time Frame From the time an objective response is first noted to be either a CR or PR to the date progression is documented, assessed up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
There were no responses.
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description:
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days 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.
5.Secondary Outcome
Title Time to Disease Progression
Hide Description The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.
Time Frame Every 3 months from registration until progressive disease (PD), assessed up to 2 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were evaluable for this endpoint.
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description:
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: months
1.85
(1.77 to 3.71)
6.Secondary Outcome
Title Survival Time
Hide Description The distribution of survival times will be estimated using the Kaplan-Meier method.
Time Frame Time from registration until death due to any cause, assessed every 6 months after PD for up to 2 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
all participants were evaluable for this endpoint.
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description:
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: months
5.83
(3.38 to 7.98)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Enzyme Inhibitor Therapy)
Hide Arm/Group Description Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Enzyme Inhibitor Therapy)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treatment (Enzyme Inhibitor Therapy)
Affected / at Risk (%) # Events
Total   3/18 (16.67%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  1/18 (5.56%)  2
Gastrointestinal disorders   
Oral hemorrhage  1  1/18 (5.56%)  1
Vomiting  1  1/18 (5.56%)  1
General disorders   
Fatigue  1  1/18 (5.56%)  1
Infections and infestations   
Bladder infection  1  1/18 (5.56%)  1
Investigations   
Creatinine increased  1  1/18 (5.56%)  1
Metabolism and nutrition disorders   
Anorexia  1  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/18 (5.56%)  1
Nervous system disorders   
Taste alteration  1  1/18 (5.56%)  1
Renal and urinary disorders   
Ureteric stenosis  1  1/18 (5.56%)  1
Vascular disorders   
Hypertension  1  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Enzyme Inhibitor Therapy)
Affected / at Risk (%) # Events
Total   18/18 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  13/18 (72.22%)  32
Eye disorders   
Flashing vision  1  1/18 (5.56%)  1
Gastrointestinal disorders   
Abdominal pain  1  3/18 (16.67%)  7
Anal pain  1  1/18 (5.56%)  1
Constipation  1  1/18 (5.56%)  2
Diarrhea  1  9/18 (50.00%)  17
Ear, nose and throat examination abnormal  1  1/18 (5.56%)  3
Intra-abdominal hemorrhage  1  1/18 (5.56%)  1
Mucositis oral  1  1/18 (5.56%)  2
Nausea  1  10/18 (55.56%)  23
Stomach pain  1  1/18 (5.56%)  1
Vomiting  1  7/18 (38.89%)  12
General disorders   
Fatigue  1  17/18 (94.44%)  53
Injury, poisoning and procedural complications   
Fracture  1  1/18 (5.56%)  1
Urostomy site bleeding  1  1/18 (5.56%)  5
Investigations   
Activated partial thromboplastin time prolonged  1  1/18 (5.56%)  1
Alanine aminotransferase increased  1  1/18 (5.56%)  1
Alkaline phosphatase increased  1  1/18 (5.56%)  1
Aspartate aminotransferase increased  1  4/18 (22.22%)  11
Bilirubin increased  1  2/18 (11.11%)  2
Leukocyte count decreased  1  8/18 (44.44%)  15
Lymphocyte count decreased  1  2/18 (11.11%)  3
Neutrophil count decreased  1  3/18 (16.67%)  6
Platelet count decreased  1  10/18 (55.56%)  19
Weight loss  1  1/18 (5.56%)  1
Metabolism and nutrition disorders   
Anorexia  1  8/18 (44.44%)  19
Blood glucose increased  1  1/18 (5.56%)  1
Serum albumin decreased  1  1/18 (5.56%)  1
Serum calcium decreased  1  1/18 (5.56%)  1
Serum sodium increased  1  2/18 (11.11%)  2
Musculoskeletal and connective tissue disorders   
Back pain  1  1/18 (5.56%)  2
Bone pain  1  1/18 (5.56%)  1
Myalgia  1  1/18 (5.56%)  2
Nervous system disorders   
Taste alteration  1  1/18 (5.56%)  1
Renal and urinary disorders   
Bladder hemorrhage  1  1/18 (5.56%)  1
Protein urine positive  1  7/18 (38.89%)  20
Respiratory, thoracic and mediastinal disorders   
Bronchopulmonary hemorrhage  1  1/18 (5.56%)  1
Hemorrhage nasal  1  2/18 (11.11%)  3
Pharyngolaryngeal pain  1  1/18 (5.56%)  1
Voice alteration  1  1/18 (5.56%)  6
Skin and subcutaneous tissue disorders   
Alopecia  1  1/18 (5.56%)  6
Hand-and-foot syndrome  1  2/18 (11.11%)  4
Rash desquamating  1  1/18 (5.56%)  2
Skin hypopigmentation  1  4/18 (22.22%)  9
Vascular disorders   
Hypertension  1  9/18 (50.00%)  31
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
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: Ulka Vaishampayan, M.D.
Organization: Karmanos Cancer Institute at Wayne State University
EMail: vaishamu@karmanos.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00471536    
Other Study ID Numbers: NCI-2009-00203
NCI-2009-00203 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000543460
MAYO-MC0553
MC0553 ( Other Identifier: Mayo Clinic )
7661 ( Other Identifier: CTEP )
N01CM62205 ( U.S. NIH Grant/Contract )
First Submitted: May 8, 2007
First Posted: May 10, 2007
Results First Submitted: February 13, 2013
Results First Posted: March 21, 2013
Last Update Posted: May 30, 2014