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Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: December 20, 2005
Last updated: June 28, 2012
Last verified: June 2012
Results First Received: December 5, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Neoplasms, Endometrial
Endometrial Cancer
Intervention: Drug: topotecan

  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
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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
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  
Sponsor Terminated Study                 9  
Protocol Violation                 1  
Other (Disease Progression)                 1  

  Baseline Characteristics

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

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