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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

Phase 1
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

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

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.

Inclusion Criteria:

1. 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

2. 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.

3. Patient is at least 18 years of age.

4. Patient has an ECOG performance status of 0-2.

5. 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.

6. Patients must be informed of the investigational nature of this study and give
written IRB-approved informed consent according to institutional guidelines.

7. 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.

8. 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.

9. 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.

Exclusion Criteria:

1. Any concurrent chemotherapy.

2. Underlying medical condition that might be aggravated by treatment or that cannot be
controlled, i.e. active uncontrolled infection and cardiac dysfunction.

3. Medical and psychiatric problems of sufficient severity to limit full compliance with
the study or expose patients to undue risk.

4. Known hypersensitivity to study drugs or its analogs.

5. Failure to recover from any prior surgery within 4 weeks of study entry.

6. Pregnant or lactating.

7. 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.

8. 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.

9. Any signs of intestinal obstruction interfering with nutrition. Patient cannot
tolerate oral intake for any reason.

10. 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.

11. Any investigational drug within 30 days of first day of dosing.

12. 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response

Outcome 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.

Safety Issue:


Principal Investigator

David S. Hong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2007

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Perifosine
  • Docetaxel
  • Taxotere
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



UT MD Anderson Cancer Center Houston, Texas  77030