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Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00267488
Recruitment Status : Completed
First Posted : December 21, 2005
Results First Posted : January 28, 2010
Last Update Posted : July 11, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Neoplasms, Endometrial
Endometrial Cancer
Intervention: Drug: topotecan

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Topotecan Hydrochloride Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.

Participant Flow:   Overall Study
    Topotecan Hydrochloride
STARTED   37 
COMPLETED   26 
NOT COMPLETED   11 
Sponsor Terminated Study                9 
Protocol Violation                1 
Other (Disease Progression)                1 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Best Overall Response   [ Time Frame: Week 0 to Week 98 when endpoints were met ]

2.  Secondary:   Time to Progression   [ Time Frame: Week 0 to Week 19 when endpoints were met ]

3.  Secondary:   Overall Survival   [ Time Frame: Week 0 to Week 98 ]

4.  Secondary:   Response Duration   [ Time Frame: Week 0 to week 98 ]

5.  Secondary:   Time to Response   [ Time Frame: Week 0 to week 98 ]

6.  Secondary:   Safety and Tolerability as Summarized Through Adverse Event Reporting   [ Time Frame: Week 0 to week 98 ]


  Serious Adverse Events


  Other Adverse Events


  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
As there was only 1 responder, time to response, and duration of response were not calculated.


  More Information