Perifosine and Docetaxel in Patients With Relapsed Epithelial Ovarian Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacodynamic Trial: Molecular Marker & Imaging Studies as Primary Endpoints to Determine Optimal Biological Dosage of Perifosine, Orally Avail AKT PH Domain Inhibitor Combined w/ Docetaxel in Patients w/Relapsed Epithelial Ovarian Cancer|
- Tumor Response [ Time Frame: After the end of every 2 cycles (about every 8 weeks), an x-ray and either a CT scan or an MRI will be obtained to re-evaluate tumor response. ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Experimental: Perifosine + Docetaxel||
Loading Dose = 100 mg by mouth (PO) every 6 hours, followed by 50 mg by mouth (PO) dailyDrug: Docetaxel
75 mg/m^2 by vein over 1 hour every 4 weeks
Other Name: Taxotere
Docetaxel is a chemotherapy drug designed to kill some cancers and is believed to be slightly effective at killing blood vessels in cancers.
Perifosine is a new drug that may help docetaxel be more effective in causing cancer cells to die. Perifosine alone may slow cancer cell growth by targeting an abnormal pathway in your ovarian cancer cells.
If you are found to be eligible to take part in this study, you will receive your dose of perifosine by mouth every 6 hours on Day 1 of therapy. The actual number of pills in your dose depends upon which dose level you are assigned to. You will then continue receiving perifosine by mouth once a day for 20 more days. Each cycle of treatment is about 28 days.
On Day 5 of therapy, of the first cycle only, you will have blood drawn (about 2.5 tablespoons) performed, and 5 hair follicles and ascites collected, if available. If you do not have ascites, you will have a FNA performed on your tumor.
On Day 8 of therapy, you will have a DCE-MRI. On Day 10 of therapy, you will have a PET scan. Your treatment schedule for each cycle will usually be the same. There may be a one-day difference in the treatment schedules.
After the first cycle is completed, you will begin receiving docetaxel, on Day 2 of therapy of each cycle of treatment, as an injection in a vein over 60 minutes at the M. D. Anderson infusion center. The second cycle of treatment will start on Day 29.
Within 72 hours of the start of each cycle, you will have blood (about 1 tablespoon) and urine collected for routine tests . After you receive the drugs, you will have weekly blood tests (about 1 tablespoon) to evaluate your well being. Before the start of each cycle of therapy, you will have a physical exam, and your medical history will be recorded. You will also be called by the study doctor or staff to ask questions about any side effects you may be experiencing during therapy. After the end of every 2 cycles (about every 8 weeks), you will have an x-ray and either a CT scan or an MRI to re-evaluate your cancer.
You may be given treatment on this study as long as your disease does not get worse. Your physician will discuss with you the maximum number of treatment cycles you will receive. You will be taken off this study if your disease gets worse or if you experience any intolerable side effects.
After your participation in this study has ended, you will come back for a follow-up visit. At this visit, you will have your medical history recorded and a physical exam. You will have blood (about 1 tablespoon) and urine collected for routine tests. You may also have a CT scan or an MRI to re-measure and re-evaluate your cancer.
You will have follow-up for as long as needed after you have completed treatment with perifosine plus docetaxel. You will either be contacted by phone or asked to come to the clinic for a routine visit. You will be contacted every 8 weeks. You will have radiographic evaluations, by either a CT or an MRI, done every 12 weeks to evaluate your cancer growth or until you start on another anticancer therapy.
This is an investigational study. Perifosine has been authorized by the FDA for use in research only. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431054
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David S. Hong, MD||UT MD Anderson Cancer Center|