Beta-Blocker / Ovarian
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Purpose
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 | Intervention |
|---|---|
|
Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer |
Drug: Propranolol Drug: Chemotherapy Procedure: Surgery Behavioral: Questionnaire |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients |
- Feasibility of Beta-Blocker Plus Chemotherapy in Ovarian Cancer [ Time Frame: 6 chemotherapy cycles (3 week cycles for total 18 weeks) ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 25 |
| Study Start Date: | March 2012 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Stages II-IV of the above cancer
- Patients to be scheduled for a planned tumor debulking
- Intention for chemotherapy administration at MD Anderson Cancer Center
- Zubrod performance status 0-2
- 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.
- (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
- 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.
- An approved informed consent and authorization permitting release of personal health information must be signed by patient or guardian.
- Age >/= 18 years at MDACC and age >/= 18 to < /= 64 at LBJ
- Patients of childbearing age must have a negative pregnancy test.
- Patients who receive neoadjuvant chemotherapy for their ovarian, primary peritoneal, or fallopian tube cancer
Exclusion Criteria:
- 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.
- 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.
- 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.
- 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.
- 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.
- Metastases to the ovaries from other organs except fallopian tube or primary peritoneal carcinoma
- Use of systemic glucocorticoids such as Prednisone or Decadron in the last month
- Inability to accurately answer questions (e.g. dementia, brain metastases) or speak English or Spanish
- Cirrhosis of the liver
- Patients with a Zubrod Performance status 3 or 4
- Age < 18 years at MDACC and age < /= 18 to >/= 65 at LBJ
- Comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis C, AIDS or HIV, lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis.
- Any patients already on beta-blockers or contraindicated to receive beta-blockers.
- Hypersensitivity to propranolol, or beta-blockers
- Uncompensated congestive heart failure
- Cardiogenic shock
- Severe sinus bradycardia; heart block, second or third degree or sick sinus syndrome (if no artificial pacemaker present)
- Severe hyperactive airway disease (chronic obstructive pulmonary disease, asthma)
- Any patients planning to receive Avastin or any other anti-angiogenic drugs.
- 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."
Contacts and Locations| Contact: Lois M. Ramondetta, MD | 713-745-0307 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Lois M. Ramondetta, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01504126 History of Changes |
| Other Study ID Numbers: | 2011-0800 |
| Study First Received: | January 3, 2012 |
| Last Updated: | November 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
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 Propranolol Beta-blocker |
Additional relevant MeSH terms:
|
Carcinoma Ovarian Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms 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 Propranolol Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on May 16, 2013