Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431054
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2007-02-02
Brief Title:
Perifosine and Docetaxel in Patients With Relapsed Epithelial Ovarian Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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 wRelapsed Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to find out if a combination treatment of perifosine and docetaxel will help shrink or slow the growth of cancer cells in recurrent ovarian cancer The safety of this combination treatment will also be studied
Detailed Description:
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 25 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
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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None