Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer
This study has been completed.
Information provided by (Responsible Party):
First received: December 20, 2005
Last updated: June 28, 2012
Last verified: June 2012
The purpose of this study is to find out if Hycamtin given weekly is safe and effective for treating your endometrial cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Phase II, Multicenter Study of Intravenous Weekly Topotecan in Subjects With Recurrent or Persistent Endometrial Cancer|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Malignant Mesenchymal Tumor Soft Tissue SarcomaU.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Best Overall Response [ Time Frame: Week 0 to Week 98 when endpoints were met ] [ Designated as safety issue: No ]Tumor response based on GOG (Gynecological Oncology Group) modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. A 4-point scale used specifying tumor response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions; (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; (PD): At least a 20% increase in the sum of the LD of target lesions
Secondary Outcome Measures:
- Time to Progression [ Time Frame: Week 0 to Week 19 when endpoints were met ] [ Designated as safety issue: No ]Kaplan-Meier Estimate. Time to progression is defined as time from start of treatment until the first documented sign of disease progression or death due to progressive disease. Subjects who have not progressed or died at the time of analysis will be censored at the time of initiation of alternative anti-cancer therapy or time of last contact. Percentiles represent a set of points on a scale arrived at by dividing a group into parts in order of magnitude.
- Overall Survival [ Time Frame: Week 0 to Week 98 ] [ Designated as safety issue: No ]Kaplan-Meier Estimate. Overall survival is defined as time from start of treatment until death due to any cause. Subjects who are alive at the time of analysis will be censored at the time of last contact.
- Response Duration [ Time Frame: Week 0 to week 98 ] [ Designated as safety issue: No ]The time from initial documented response to the first documented sign of progression or death due to progressive disease. Not calculated due to no Complete response and only 1 partial response.
- Time to Response [ Time Frame: Week 0 to week 98 ] [ Designated as safety issue: No ]The time from start of treatment until the first documented response. Not calculated due to no Complete response and only 1 partial response.
- Safety and Tolerability as Summarized Through Adverse Event Reporting [ Time Frame: Week 0 to week 98 ] [ Designated as safety issue: No ]AE = Adverse Event reported at a frequency of greater than or equal to 16%. SAE = Serious Adverse Events where all were reported at 0% frequency.
|Study Start Date:||October 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Other Name: topotecan
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267488
Show 24 Study Locations
Show 24 Study Locations
Sponsors and Collaborators
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|