Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
This trial is active, not recruiting.
|Conditions||ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer|
|Treatments||propranolol, chemotherapy, surgery, questionnaire|
|Sponsor||M.D. Anderson Cancer Center|
|Collaborator||Sprint for Life|
|Start date||March 2012|
|End date||March 2019|
|Trial size||25 participants|
|Trial identifier||NCT01504126, 2011-0800, NCI-2012-00056|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||single group assignment|
Feasibility of Beta-Blocker Plus Chemotherapy in Ovarian Cancer
time frame: 6 chemotherapy cycles (3 week cycles for total 18 weeks)
Female participants at least 18 years old.
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."
|Official title||Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients|
|Principal investigator||Lois M. Ramondetta, MD|
|Description||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 decide 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 20 will be enrolled at MD Anderson. Up to 5 will be enrolled at Harris Health System.|
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