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
Overview
- Phase
- Not Applicable
- Intervention
- Liposomal Doxorubicin
- Conditions
- Ovarian Cancer
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Assess Feasibility
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must have history of histologically or cytologically confirmed epithelial ovarian cancer with recurrence.
- •Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral computed tomography CT) scan.
- •May have had only 2 prior chemotherapy regimens, with at least one regimen containing platinum, and disease recurrence or progression occurring between 0 to 12 months (1 to 365 days)from the platinum-containing regimen. Patients who have been treated with consolidation treatment are allowed and the consolidation will not be considered a separate regimen. Hormonal therapy and immunotherapy will not be considered a prior chemotherapy regimen. Hormonal therapies given to treat the patient's cancer should be stopped at least 30 days prior to dosing on this trial. Typical low-dose hormone replacement therapy to treat postmenopausal symptoms may be continued at the treating physician's discretion.
- •Life expectancy \>6 months.
- •ECOG performance status 2 or less (Karnofsky 60%).
- •Must have normal organ and marrow function as defined below:
- •leukocytes 3,000/microL
- •absolute neutrophil count 1,500/ microL
- •platelets 100,000/microL
- •total bilirubin ≤1.5 X institutional upper limit of normal(ULN) aspartate aminotransferase \[AST(SGOT)\]/alanine aminotransferase \[ALT(SGPT)\] ≤2.5 X ULN creatinine within normal institutional limits OR creatinine clearance 60mL/min/1.73m2 for patients with creatinine levels above institutional normal
Exclusion Criteria
- •Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not version 13, 01/10/08 MCC 15042 16 recovered from adverse events due to agents administered more than 4 weeks earlier.
- •May not be receiving any other investigational agents concurrently.
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to liposomal doxorubicin or topotecan.
- •Myocardial infarction within 6 months. History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Women who are pregnant.
- •Women who are breastfeeding should discontinue breastfeeding.
- •Human Immunodeficiency Virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions and increased toxicity.
- •Patients may have had no other malignancies in the prior 5 years other than non-metastatic, locally-controlled, non-melanomatous cutaneous cancers.
Arms & Interventions
Liposomal Doxorubicin
Liposomal Doxorubicin - Chemotherapy single agent systemic.
Intervention: Liposomal Doxorubicin
Topotecan
Topotecan - Chemotherapy single agent systemic.
Intervention: Topotecan
Outcomes
Primary Outcomes
Assess Feasibility
Time Frame: 1 year, 2 months
Number of patients meeting 3 week feasibility window which was set as the benchmark.
Interpret Genomic Array
Time Frame: 1 year, 2 months
Number of patients with biopsiable tumor in sufficient quantity and quality that will result in an interpretable genomic array.
Secondary Outcomes
- Response Rate(1 year, 2 months)