Letrozole in Patients With Ovarian Tumors

This study has been terminated.
(Terminated due to slow patient accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00505661
First received: July 19, 2007
Last updated: April 16, 2012
Last verified: April 2012
Results First Received: September 28, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Intervention: Drug: Letrozole

  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
Recruitment Period: 09/24/03 through 01/30/08. All participants recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study terminated early due to slow patient accrual.

Reporting Groups
  Description
Letrozole 2.5 mg by mouth (PO) daily

Participant Flow:   Overall Study
    Letrozole  
STARTED     16  
COMPLETED     12  
NOT COMPLETED     4  
Not Eligible                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Letrozole 2.5 mg by mouth (PO) daily

Baseline Measures
    Letrozole  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Median ( Full Range )
  54  
  ( 43 to 77 )  
Gender  
[units: participants]
 
Female     16  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures

1.  Primary:   Objective Response Rate Following Treatment With Letrozole   [ Time Frame: 2 month intervals for first 2 years ]


  Serious Adverse Events


  Other Adverse Events


  More Information