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| Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Collaborator: |
Department of Defense |
| Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00720096 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Ovarian Cancer |
Drug: Liposomal Doxorubicin Drug: Topotecan |
| Study Type: | Interventional |
| 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 |
| Enrollment: | 4 |
| Study Start Date: | July 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Liposomal Doxorubicin
Liposomal Doxorubicin - Chemotherapy single agent systemic.
|
Drug: Liposomal Doxorubicin
Liposomal Doxorubicin 40 mg/m2 q 28 days
Other Name: Doxil
|
|
Experimental: Topotecan
Topotecan - Chemotherapy single agent systemic.
|
Drug: Topotecan
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must have normal organ and marrow function as defined below:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Robert Wenham, M.D., M.S., H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00720096 History of Changes |
| Other Study ID Numbers: | MCC-15042, NFGC 12-12990-01-29 |
| Study First Received: | July 21, 2008 |
| Results First Received: | October 15, 2010 |
| Last Updated: | April 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Persistent Ovarian Cancer Genomic directed salvage chemotherapy Genomic Microarray |
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Doxorubicin Topotecan Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |