Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Cytogen Corporation
Information provided by (Responsible Party):
Seth Lerner, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00710970
First received: July 7, 2008
Last updated: July 22, 2013
Last verified: July 2013
Results First Received: December 27, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Urinary Bladder Neoplasms
Intervention: Drug: Tamoxifen

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients presenting to the Scott Department of Urology for management of recurrent bladder cancer and fulfill the following criteria will be recruited.

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
Single Arm Receiving 20mg Tamoxifen Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.

Participant Flow:   Overall Study
    Single Arm Receiving 20mg Tamoxifen
STARTED   28 
COMPLETED   18 
NOT COMPLETED   10 
Lost to Follow-up                8 
Never took drug                2 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Single Arm Receiving 20mg Tamoxifen Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.

Baseline Measures
   Single Arm Receiving 20mg Tamoxifen 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   11 
>=65 years   17 
Age 
[Units: Years]
Mean (Standard Deviation)
 69  (10.844) 
Gender 
[Units: Participants]
 
Female   2 
Male   26 
Region of Enrollment 
[Units: Participants]
 
United States   21 
Italy   7 


  Outcome Measures

1.  Primary:   Sustained Stable Disease is Considered to be Clinically Important. Hence, 4-month Freedom From Progression (FFP) (Stable Disease + Partial Response + Complete Response) is Chosen as the Primary End-point Instead of Response Rate.   [ Time Frame: 4 months ]

2.  Primary:   Tamoxifen : Tamoxifen is Administered at 20 mg/Day as a Single Daily Oral Dose. Tamoxifen is Continued Until Progressive Disease or Intolerable Grade 3 or 4 Side Effects Occur Due to Tamoxifen.   [ Time Frame: To progression ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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:  
Name/Title: Seth P. Lerner, M.D., F. A. C. S.
Organization: Baylor College of Medicine
phone: 713-798-6841
e-mail: slerner@bcm.edu


Publications:

Responsible Party: Seth Lerner, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00710970     History of Changes
Obsolete Identifiers: NCT00589017
Other Study ID Numbers: H-16848
Study First Received: July 7, 2008
Results First Received: December 27, 2012
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board