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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01504126
Recruitment Status : Active, not recruiting
First Posted : January 5, 2012
Last Update Posted : December 15, 2017
Sprint for Life
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if it is feasible to give a beta-blocker such as Inderal (propranolol hydrochloride) with standard chemotherapy (paclitaxel and carboplatin or possibly docetaxel) to treat ovarian cancer. The safety of propranolol hydrochloride will also be studied.

Propranolol hydrochloride is designed to block certain chemicals that affect the heart. Researchers want to learn if this might also boost the immune system, allowing the chemotherapy to be more effective.

Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.

Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Drug: Propranolol Drug: Chemotherapy Procedure: Surgery Behavioral: Questionnaire Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
Actual Study Start Date : March 2012
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: Propranolol
Propranolol 20 mg orally twice a day for 48-72 hours preoperatively, resumed post-operative tumor reduction continued to chemotherapy completion. Intravenous platinum or taxane chemotherapy (without bevacizumab) for six 3-week cycles.
Drug: Propranolol
20 mg by mouth twice a day for 48-72 hours preoperatively. Resume when participant tolerating oral intake post-operatively until completion of chemotherapy.
Drug: Chemotherapy
Within 3 weeks of surgery, standard intravenous platinum or taxane chemotherapy (without bevacizumab) over 3-week cycles.
Procedure: Surgery
Initial tumor reductive surgery.
Behavioral: Questionnaire
Completion of questionnaires at baseline and after cycles 3 and 6 of chemotherapy.
Other Name: Survey

Primary Outcome Measures :
  1. Feasibility of Beta-Blocker Plus Chemotherapy in Ovarian Cancer [ Time Frame: 6 chemotherapy cycles (3 week cycles for total 18 weeks) ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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. Patients with primarily carcinoma histology but mixed features can be included. 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 </=1.5 x institutional upper limit normal; SGOT and alkaline phosphatase </=2.5 x institutional upper limit normal. (e) Neurologic function: Neuropathy (sensory and motor) </= grade 1 according to Common Toxicity Criteria for Adverse Events version 3 (CTCAE). (f) Blood coagulation parameters: PT such that international normalized ratio (INR) is </= 1.5 (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 </= 140, DBP </= 90
  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. No stromal cancers or germ cell cancers or low malignant potential. 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 disease.
  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 within 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 arthritis.
  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."

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01504126

United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Sprint for Life
Principal Investigator: Lois M. Ramondetta, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01504126     History of Changes
Other Study ID Numbers: 2011-0800
NCI-2012-00056 ( Registry Identifier: NCI CTRP )
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents