Genomic Directed Salvage Chemotherapy With Either Liposomal Doxorubicin Or Topotecan
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Assess Feasibility [ Time Frame: 1 year, 2 months ] [ Designated as safety issue: No ]Number of patients meeting 3 week feasibility window which was set as the benchmark.
- Interpret Genomic Array [ Time Frame: 1 year, 2 months ] [ Designated as safety issue: No ]Number of patients with biopsiable tumor in sufficient quantity and quality that will result in an interpretable genomic array.
- Response Rate [ Time Frame: 1 year, 2 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: Liposomal Doxorubicin
Liposomal Doxorubicin - Chemotherapy single agent systemic.
Drug: Liposomal Doxorubicin
Liposomal Doxorubicin 40 mg/m2 q 28 days
Other Name: Doxil
Topotecan - Chemotherapy single agent systemic.
Other Name: Hycamtin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720096
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Robert M. Wenham, M.D., M.S.||H. Lee Moffitt Cancer Center and Research Institute|