Genomic Directed Salvage Chemotherapy With Either Liposomal Doxorubicin Or Topotecan
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ClinicalTrials.gov Identifier: NCT00720096 |
Recruitment Status :
Terminated
(Funds for this project have been spent, and it is thereby terminated.)
First Posted : July 22, 2008
Results First Posted : February 16, 2011
Last Update Posted : January 2, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | July 21, 2008 | |||
First Posted Date ICMJE | July 22, 2008 | |||
Results First Submitted Date ICMJE | October 15, 2010 | |||
Results First Posted Date ICMJE | February 16, 2011 | |||
Last Update Posted Date | January 2, 2018 | |||
Study Start Date ICMJE | July 2008 | |||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Determine response rate of array directed chemotherapy. [ Time Frame: Dependant upon results ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Response Rate [ Time Frame: 1 year, 2 months ] Determine response rate of array directed chemotherapy (as defined as the proportion of patients achieving complete or partial responses with a predictive score >/= 0.5 for either chemotherapy). As well as evaluate the accuracy of the chemosensitivity profiles for differentiating doxorubicin and topotecan responsive cancers. Due to the limited sample size the interpretation is limited. Results data for this outcome is not posted.
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Original Secondary Outcome Measures ICMJE |
Overall response rate, duration of patient response. Refine methodologies for full genome expression profiling in a clinical trial; evaluate the accuracy of chemosensitivity profiles for differentiating doxorubicin and topotecan responsive cancers. [ Time Frame: Dependent upon results ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Genomic Directed Salvage Chemotherapy With Either Liposomal Doxorubicin Or Topotecan | |||
Official Title ICMJE | A Pilot Prospective Trial Of Genomic Directed Salvage Chemotherapy With Either Liposomal Doxorubicin Or Topotecan In Recurrent Or Persistent Ovarian Cancer Within 12 Months Of Platinum-Based Chemotherapy | |||
Brief Summary | This pilot study will help us to determine the success of using a special technique called microarray technology to examine cancer genes in order to predict how individual women will respond to one of two therapies, liposomal doxorubicin or topotecan, and which will be more effective in treating ovarian cancer that has returned (recurrent ovarian cancer). We believe that this study may lead to a means by which microarray technology can predict the most effective treatment decision, based on the genetic characteristics of her tumor tissue, for a woman with recurrent ovarian cancer. Another purpose of this study is to determine how quickly a woman with recurrent ovarian cancer will respond to treatment (treatment response rate) and to evaluate the accuracy of the genomic predictions. Recent data suggest that microarray technology can predict a patient's response to chemotherapy; this has not yet been proven in a forward-looking study which is why we are conducting this research. |
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Detailed Description | Patients who take part in the study will have an initial visit and undergo a CT guided core biopsy. Using tissue from a CT guided core biopsy, microarray analysis will be performed to help predict which of the two drugs appears to be better suited to individual genomic factors. The results will result in being assigned to treatment with either liposomal doxorubicin or topotecan. Patients who receive liposomal doxorubicin - IV chemotherapeutic treatment will occur 3 times, 28 days apart, weeks 1,5,and 9. At each of these visits patients will be evaluated and have blood work to check their liver tests and electrolytes. Every 8 weeks patients will have a radiologic evaluation of their tumor. Patients who receive topotecan - IV chemotherapeutic treatment will occur 4 times, 21 days apart, weeks 1,4,7, and 10. At each of these visits patients will be evaluated and have blood work to check levels of liver tests and electrolytes. Every 8 weeks patients will have a radiologic evaluation of their tumor. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Ovarian Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* 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 | Terminated | |||
Actual Enrollment ICMJE |
4 | |||
Original Estimated Enrollment ICMJE |
48 | |||
Actual Study Completion Date ICMJE | October 2009 | |||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00720096 | |||
Other Study ID Numbers ICMJE | MCC-15042 NFGC 12-12990-01-29 ( Other Identifier: NFGC ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | H. Lee Moffitt Cancer Center and Research Institute | |||
Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | |||
Collaborators ICMJE | United States Department of Defense | |||
Investigators ICMJE |
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PRS Account | H. Lee Moffitt Cancer Center and Research Institute | |||
Verification Date | December 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |