Phase II, Open Label, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of the Combination RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
Docetaxel is a drug approved for the treatment of metastatic breast cancer in patients who
are either newly diagnosed or have failed earlier chemotherapy. RAD001 is an investigational
drug that has shown to have anticancer properties. It also works by weakening the immune
system. RAD001 works by blocking some of the steps required for cancer growth. The
researcher hopes that RAD001 may increase the anticancer activity of docetaxel.
If you are found to be eligible to take part in this study, you will receive docetaxel by
vein on Day 1 over one hour. RAD001 will be given by mouth on Days 1 and 8. RAD 001 will be
given on an empty stomach or after a light meal. You will repeat this treatment every 21
days. Three (3 ) weeks equals 1 cycle.
Patients who participated on the first phase of study numbered 2004-0758 will be eligible
for the study. The study will done using the highest dose of RAD001 and docetaxel that was
found to be safe and effective during the first phase of the study.
Dexamethasone will be given by mouth twice a day for 3 days, starting the day before you
receive docetaxel. Dexamethasone helps decrease the risk of and control nausea, vomiting,
and fluid retention.
Blood (between 1-2 teaspoons) will be drawn for routine tests at each visit. X-rays and
scans (CT or MRI) will be done every 6 weeks to see if the tumor is responding to treatment.
After 6 cycles of the combination, docetaxel will be stopped and you will continue to take
RAD001 alone. However, you may be able to take more than 6 cycles of the combination if you
are not having any side effects and is found to be of benefit by your primary doctor.
Once you go off treatment, you will have a physical exam, including routine blood tests (1-2
This is an investigational study. Docetaxel is approved by the FDA and commercially
available for the treatment of breast cancer. RAD001 is authorized for use in research only.
About 65 patients will take part in the study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Response to combination RAD001 + docetaxel
Clinical efficacy of the combination regimens in the participant population as shown by response (according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria). Response evaluated with each 3 week cycle.
Stacy Moulder, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
2004-0758 Phase II