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Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients

18 Years
Open (Enrolling)
Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer

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Trial Information

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.

Inclusion Criteria:

1. Suspected preoperative diagnosis of invasive epithelial ovarian cancer, primary
peritoneal carcinoma, fallopian tube cancer based on imaging and Ca 125. Histologic
epithelial cell types are eligible: serous adenocarcinoma, endometrioid
adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell
carcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified. The
surgically confirmed histologic features must be compatible with primary Müllerian
epithelial adenocarcinoma

2. Stages II-IV of the above cancer

3. Patients to be scheduled for a planned tumor debulking

4. Intention for chemotherapy administration at MD Anderson Cancer Center

5. Zubrod performance status 0-2

6. Patients must have adequate: (a) Bone marrow function: Absolute neutrophil count
(ANC) >/=1500/ml. (b) Platelets >100,000/mL. (c) Renal function: Creatinine clearance
(CrCl) > 50 mL/min. (d) Hepatic function: Bilirubin limit normal; SGOT and alkaline phosphatase normal. (e) Neurologic function: Neuropathy (sensory and motor) to Common Toxicity Criteria for Adverse Events version 3 (CTCAE). (f) Blood
coagulation parameters: PT such that international normalized ratio (INR) is (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of
therapeutic warfarin for the management of venous thrombosis including pulmonary
embolus) and a PTT <1.2 times institutional upper limit of normal.

7. (CONTINUED FROM NO. 6) Patient must have adequate: (g) Hemodynamics: Pulse >/= 60
beat per minute (bpm); Systolic blood pressure (SBP) > 110 mmHg; diastolic blood
pressure (DBP) >/= 60 mmHg. (h) Normotensive individuals not already on beta blockers
(may be on other anti hypertensives): SBP
8. Surgery or neoadjuvant chemotherapy must be scheduled at least 72 hours in advance in
order for the patient to take at least 48 hours of prescribed Propranolol and have
stable vital signs confirmed.

9. An approved informed consent and authorization permitting release of personal health
information must be signed by patient or guardian.

10. Age >/= 18 years at MDACC and age >/= 18 to < /= 64 at LBJ

11. Patients of childbearing age must have a negative pregnancy test.

12. Patients who receive neoadjuvant chemotherapy for their ovarian, primary peritoneal,
or fallopian tube cancer

Exclusion Criteria:

1. Patients with non-epithelial ovarian tumors that do not require adjuvant
chemotherapy, borderline epithelial ovarian tumor, or recurrent invasive epithelial
ovarian, low grade ovarian cancer, primary peritoneal, or fallopian tube cancer
treated with surgery only (such as patients with stage IA or IB). Patients with a
prior diagnosis of a borderline tumor that was surgically resected and who
subsequently develop an unrelated new invasive epithelial ovarian, primary
peritoneal, or fallopian tube cancer are eligible, provided that they have not
received chemotherapy for any tumor. Patients found post operatively to have
ineligible histology will be removed from the study.

2. Patients who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis are excluded. Prior radiation therapy for localized cancer of the breast,
head and neck, or skin is permitted provided that it was completed more than 3 years
prior to registration, and the patient remains free of recurrent or metastatic

3. Patients with a synchronous primary endometrial cancer, or a past history of primary
endometrial cancer are excluded unless all of the following conditions are met: stage
not greater than stage IA; no more than superficial myometrial invasion, without
vascular or lymphatic invasion; no poorly differentiated subtypes, including
papillary serous, clear cell, or other FIGO grade 3 lesions.

4. Patients who have received targeted therapy (including but not limited to vaccines,
antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their
primary peritoneal, ovarian, or fallopian tube cancer.

5. With the exception of non-melanoma skin cancer and other specific malignancies as
noted above, patients with other invasive malignancies who had (or have) any evidence
of the other cancer present with the last five years or whose previous cancer
treatment contraindicates this protocol therapy are excluded.

6. Metastases to the ovaries from other organs except fallopian tube or primary
peritoneal carcinoma

7. Use of systemic glucocorticoids such as Prednisone or Decadron in the last month

8. Inability to accurately answer questions (e.g. dementia, brain metastases) or speak
English or Spanish

9. Cirrhosis of the liver

10. Patients with a Zubrod Performance status 3 or 4

11. Age < 18 years at MDACC and age < /= 18 to >/= 65 at LBJ

12. Comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis
C, AIDS or HIV, lupus erythematosus, mixed connective tissue disease, rheumatoid

13. Any patients already on beta-blockers or contraindicated to receive beta-blockers.

14. Hypersensitivity to propranolol, or beta-blockers

15. Uncompensated congestive heart failure

16. Cardiogenic shock

17. Severe sinus bradycardia; heart block, second or third degree or sick sinus syndrome
(if no artificial pacemaker present)

18. Severe hyperactive airway disease (chronic obstructive pulmonary disease, asthma)

19. Any patients planning to receive Avastin or any other anti-angiogenic drugs.

20. Patients with brittle diabetes mellitus (DM). Brittle diabetes mellitus is a type of
diabetes when a person's blood glucose (sugar) level often swings quickly from high
to low and from low to high. Also called "unstable diabetes" or "labile diabetes."

Type of Study:


Study Design:

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

Outcome Measure:

Feasibility of Beta-Blocker Plus Chemotherapy in Ovarian Cancer

Outcome Description:

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

Outcome Time Frame:

6 chemotherapy cycles (3 week cycles for total 18 weeks)

Safety Issue:


Principal Investigator

Lois M. Ramondetta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2012

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary peritoneal carcinoma
  • Fallopian tube cancer
  • Invasive epithelial ovarian cancer
  • Serous adenocarcinoma
  • Endometrioid adenocarcinoma
  • Mucinous adenocarcinoma
  • Undifferentiated carcinoma
  • Clear cell carcinoma
  • Mixed epithelial carcinoma
  • Adenocarcinoma not otherwise specified
  • Primary Müllerian epithelial adenocarcinoma
  • Propranolol
  • Beta-blocker
  • Carcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030