Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
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.
|Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer||Drug: Propranolol Drug: Chemotherapy Procedure: Surgery Behavioral: Questionnaire|
|Study Design:||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|
- 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
|Actual Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
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.
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Principal Investigator:||Lois M. Ramondetta, MD||M.D. Anderson Cancer Center|