Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316173
First received: April 19, 2006
Last updated: March 17, 2011
Last verified: March 2011
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Tracking Information | |||||
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First Received Date ICMJE | April 19, 2006 | ||||
Last Updated Date | March 17, 2011 | ||||
Start Date ICMJE | March 2005 | ||||
Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants With the Indicated Response [ Time Frame: From start of treatment to evidence of CR or PR (up to 39.3 weeks). ] [ Designated as safety issue: No ] Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization [WHO] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: >50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: >25% increase in measurements of lesions or appearance of new lesions). |
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Original Primary Outcome Measures ICMJE |
Overall response rate | ||||
Change History | Complete list of historical versions of study NCT00316173 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Time to Disease Progression, Overall survival, Adverse Events, Change in CA-125 levels | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer | ||||
Official Title ICMJE | An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer | ||||
Brief Summary | This study was designed to find the most effective and safest doses of both HYCAMTIN and CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | Experimental: Single-arm
HYCAMTIN at a dose of 2.0 - 2.5mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1, every 21 days
Interventions:
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Publications * | Schwartz PE, Rose PG, Monk BJ, et al. An open-label, single arm, phase II study of IV weekly (days 1 and 8) topotecan in combination with carboplatin (day 1) every 21 days as second-line therapy in subjects with platinum sensitive relapsed ovarian cancer: First stage results. J Clin Oncol. 2008; 26 (May 20 suppl). Abstract 16518 | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 77 | ||||
Completion Date | March 2009 | ||||
Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00316173 | ||||
Other Study ID Numbers ICMJE | 104864/902 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | March 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |