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Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00112905
First received: June 2, 2005
Last updated: May 20, 2014
Last verified: December 2012
Results First Received: December 30, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Bladder
Distal Urethral Cancer
Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
Proximal Urethral Cancer
Recurrent Bladder Cancer
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
Recurrent Urethral Cancer
Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
Squamous Cell Carcinoma of the Bladder
Stage III Bladder Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Urethral Cancer Associated With Invasive Bladder Cancer
Interventions: Drug: sorafenib tosylate
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was activated on 10/26/2005. The TCC (transitional cell carcinoma) cohort was suspended for an efficacy evaluation on 10/30/2006 after reaching its first stage accrual goal. A total of 27 patients entered the TCC cohort, and no patient entered the non-TCC cohort. The study was terminated on March 10th, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TCC (Transitional Cell Carcinoma) Cohort Sorafenib was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If sorafenib was taken with meals, patients were instructed to take sorafenib tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies. Patients were instructed to keep a pill diary and record the pills they took each day.

Participant Flow:   Overall Study
    TCC (Transitional Cell Carcinoma) Cohort  
STARTED     27  
Eligible and Treated     22  
COMPLETED     15  
NOT COMPLETED     12  
Adverse Event                 4  
Death                 1  
Ineligibility                 5  
Alternative treatment                 1  
performance status was deteiorating                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TCC Cohort

Only eligible and treated patients are included in the analysis.

BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies.


Baseline Measures
    TCC Cohort  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Median ( Full Range )
  66  
  ( 37 to 81 )  
Gender [1]
[units: participants]
 
Female     8  
Male     14  
[1] Gender of eligible participants who began treatment.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Kaplan-Meier Estimate of Progression-free Survival at 4 Months   [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year. ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year. ]

3.  Secondary:   Overall Survival   [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year. ]

4.  Secondary:   Best Overall Response by RECIST   [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00112905     History of Changes
Other Study ID Numbers: NCI-2012-02975, NCI-2012-02975, U10CA021115, E1804, E1804, U10CA021115
Study First Received: June 2, 2005
Results First Received: December 30, 2010
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration