Ovarian CancerPhase 1NCT00431054
Perifosine and Docetaxel in Patients With Relapsed Epithelial Ovarian Cancer
A Phase 1 study testing Perifosine and Docetaxel in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Perifosine and Docetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or gynecologic primary peritoneal cancer. All patients must be platinum resistant or refractory that is defined as tumor progression during platinum-based treatment or less than 6 months of treatment-free interval.
- All patients have to have tumor that is accessible to biopsy. In addition, patients have to have another tumor that a) will not be biopsied; and for the purpose of DCE-MRI and PET studies, b) is at least 2cm in size per radiologic measurement.
- Patient is at least 18 years of age.
- Patient has an ECOG performance status of 0-2.
- Patient is willing to comply with study procedures to have biopsies of tumor and blood collection for molecular marker and biological marker studies; and two PET scans and two dynamic MRIs for imaging studies and follow-up examinations for toxicity profile.
- Patients must be informed of the investigational nature of this study and give written IRB-approved informed consent according to institutional guidelines.
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- If patient is of child-bearing potential, she has agreed to practice an effective method of birth control during the study and 6 months after the last study dose.
- Patient has adequate liver and renal function: serum bilirubin =/<2.0 mg/dL; ALT=/<3x uln. If the patient has hepatic metastasis, ALT =/<5x uln. Serum creatinine =/<2.0 mg/dL or a calculated creatinine clearance of at least 50 ml/min.
- Patient has adequate bone marrow reserve. ANC=/>1,500/mm^3, Platelet count =/>100,000/mm^3, and Hemoglobin =/>9.0g/dL without bone marrow support.
Who cannot join
- Any concurrent chemotherapy.
- Underlying medical condition that might be aggravated by treatment or that cannot be controlled, i.e. active uncontrolled infection and cardiac dysfunction.
- Medical and psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.
- Known hypersensitivity to study drugs or its analogs.
- Failure to recover from any prior surgery within 4 weeks of study entry.
- Pregnant or lactating.
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- On combination anti-retroviral therapy for HIV because of possible pharmacokinetic interaction with perifosine. Every effort will be made to avoid known inhibitors or inducers of P450 enzymes for potential drug-drug interaction.
- Any treatment specific for tumor control within 3 weeks of study drugs (within 6 wks. for nitrosoureas or mitomycin C) or failure to recover from the toxic effect of any of these therapies prior to study entry.
- Any signs of intestinal obstruction interfering with nutrition. Patient cannot tolerate oral intake for any reason.
- A known history of CNS metastasis unless the patient has had treatment with surgery or radiation therapy, is neurologically stable, and does not require oral or intravenous corticosteroids or anticonvulsants.
- Any investigational drug within 30 days of first day of dosing.
- History of high-dose chemotherapy for ovarian cancer, defined as the intensity and/or the density of a chemotherapeutic agent beyond standard of care for ovarian cancer treatment. i.e. Treatment with carboplatin at AUC 11 is considered as high-dose chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 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.
- Conditions
- Ovarian Cancer
- Being tested
- Perifosine, Docetaxel
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Perifosine, Docetaxel, Taxotere
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerifosineDrug
Loading Dose = 100 mg by mouth (PO) every 6 hours, followed by 50 mg by mouth (PO) daily
DocetaxelDrug
Also called Taxotere
75 mg/m^2 by vein over 1 hour every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Perifosine + Docetaxel | Experimental | Not described Receives: Drug: Perifosine; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Keryx Biopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- David S. Hong, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431054
- Sponsor's protocol ID
- 2004-0970
- Status last verified
- Jun 2012
- First submitted
- 2 Feb 2007
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00431054
- Acronym / sponsor ID
- 2004-0970
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Perifosine, Docetaxel, Taxotere
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Keryx Biopharmaceuticals
- Study start
- Feb 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perifosine + Docetaxel | Experimental | Drug: Perifosine, Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient has histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or gynecologic primary peritoneal cancer. All patients must be platinum resistant or refractory that is defined as tumor progression during platinum-based treatment or less than 6 months of treatment-free interval.
- All patients have to have tumor that is accessible to biopsy. In addition, patients have to have another tumor that a) will not be biopsied; and for the purpose of DCE-MRI and PET studies, b) is at least 2cm in size per radiologic measurement.
- Patient is at least 18 years of age.
- Patient has an ECOG performance status of 0-2.
- Patient is willing to comply with study procedures to have biopsies of tumor and blood collection for molecular marker and biological marker studies; and two PET scans and two dynamic MRIs for imaging studies and follow-up examinations for toxicity profile.
Key exclusion criteria (12 listed)
- Any concurrent chemotherapy.
- Underlying medical condition that might be aggravated by treatment or that cannot be controlled, i.e. active uncontrolled infection and cardiac dysfunction.
- Medical and psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.
- Known hypersensitivity to study drugs or its analogs.
- Failure to recover from any prior surgery within 4 weeks of study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerifosineLoading Dose = 100 mg by mouth (PO) every 6 hours, followed by 50 mg by mouth (PO) daily | Drug | Perifosine + Docetaxel |
| DocetaxelAlso: Taxotere75 mg/m^2 by vein over 1 hour every 4 weeks | Drug | Perifosine + Docetaxel |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S. Hong, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Perifosine and Docetaxel in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.