Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
Tests Before Treatment:
If you are found to be eligible to take part in this study, the following tests and
procedures will be performed before beginning treatment.
- You will have a physical exam, including measurement of your vital signs (blood
pressure and heart rate).
- Your medical history will be recorded, including any drugs you may have been taking and
any side effects you may have had.
- Blood (about 5 ½ teaspoons) will be drawn for biomarker testing. Biomarkers are found
in the blood and may be related to your reaction to the study drug.
- You will have an electrocardiogram (ECG) to check your heart function.
- You will be asked to fill out several questionnaires about how you have been feeling,
how your life has been affected by the disease, and your age, education, and marital
status. These questionnaires should take about 30-40 minutes to complete.
Study Drug Administration Before Treatment:
You will take propranolol by mouth 2 times a day for 48-72 hours before your treatment. You
should take it with a glass of water (about 8 ounces). If there is any concern about
starting medication, you will meet with a heart doctor before treatment. You will stop
taking propranolol with your last dose given the night before surgery.
Tests During Surgery:
During surgery, if your doctor thinks there is enough tissue available without affecting the
amount of tissue needed to make a diagnosis, leftover tumor tissue from the surgery will be
used for biomarker and immune system testing.
Once your doctor knows the final diagnosis of the pelvic mass, he/she will be able to tell
you if further treatment is needed and if you are still eligible to continue taking part in
this study. You will be taken off study if the pathology report shows there is no sign of
cancer and you do not need to receive chemotherapy.
Study Drug Administration:
After surgery, once you are able to tolerate drugs taken by mouth, you will restart taking
propranolol by mouth 2 times a day every day.
You will begin chemotherapy (carboplatin and paclitaxel or docetaxel) either before or 3
weeks after surgery. The doctor will decided when you receive chemotherapy and the schedule
of the drugs based on what is in your best interest.
You will receive paclitaxel by vein over 3 hours followed by carboplatin by vein over 1
hour. You will receive a total of 6 cycles of chemotherapy. If the doctor thinks it is in
your best interest, you may receive docetaxel by vein over 1 hour instead of paclitaxel.
If you are on a 3-week schedule, you will receive paclitaxel or docetaxel followed by
carboplatin on Day 1 of each 3-week cycle.
If you are on a weekly schedule, you will receive paclitaxel followed by carboplatin on Day
1 of each cycle. On Days 8 and 15 you will receive only paclitaxel by vein over 3 hours.
If the doctor thinks it is needed, you will start chemotherapy before your surgery. You will
have 3 cycles of chemotherapy before surgery and 3 cycles after surgery.
Study Visits After Surgery:
On Day 1 of each cycle:
- Your vital signs will be measured.
- Blood (about 1 teaspoon) will be drawn for CA-125 testing.
After Cycles 3 and 6 of chemotherapy:
- Any updates to your medical history will be recorded.
- You will have a physical exam.
- Blood (about 1 teaspoon) will be drawn for routine tests and CA-125 testing.
- Blood (about 5 ½ teaspoons) will be drawn for biomarker testing. If you have
chemotherapy before surgery, the Cycle 3 blood draw will be before surgery.
- You will fill out the study questionnaires about how you have been feeling and how your
life has been affected by the disease.
- You will have an ECG if the doctor thinks it is needed.
- After the 6th cycle only, you will have a CT scan of the abdomen and pelvis to check
the status of the disease if the doctor thinks it is needed.
Length of Dosing:
You may continue taking propranolol hydrochloride until the end of Cycle 6 of chemotherapy.
You will no longer be able to take the study drug if the disease gets worse, if intolerable
side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the follow-up visits.
Follow-up Visits:
About every 3 months for 1 year after you stop taking the study drug, the following standard
tests/procedures will be performed:
- Any updates to your medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 1 teaspoon) will be drawn for routine tests and CA-125 testing.
- You will have an ECG if the doctor thinks it is needed.
- You will have a CT scan of the abdomen and pelvis to check the status of the disease if
the doctor thinks it is needed.
Information about your health and treatment will be collected from your medical records
while you are receiving follow-up at MD Anderson and will be kept as part of the study
records. This information will include your past medical history, information from your
physical exam, your diagnosis and pathology (tissue) reports, results of routine blood
tests, current drugs you are taking, and follow-up information about your treatment, side
effects, and health.
This is an investigational study. Propranolol hydrochloride is commercially available and
FDA approved to treat high blood pressure, irregular heartbeats, and to protect the heart
after a heart attack. Giving it to patients with ovarian cancer is investigational.
Up to 25 patients will take part in this study. Up to 5 will be enrolled at Lyndon B.
Johnson General Hospital.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of Beta-Blocker Plus Chemotherapy in Ovarian Cancer
Feasibility is proportion of participants who successfully complete 6 cycles of chemotherapy (3 week cycles) and concurrent treatment with propranolol. Success rate monitored using the method described by Thall et al. Failure defined as any possible, probably, and definitely Propranolol related reason for lack of completion of 6 chemotherapy cycles
6 chemotherapy cycles (3 week cycles for total 18 weeks)
No
Lois M. Ramondetta, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2011-0800
NCT01504126
March 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |