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Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
This early phase I trial studies giving propranolol hydrochloride with standard chemotherapy in treating patients with ovarian, primary peritoneal, or fallopian tube cancer. Biological therapies, such as propranolol hydrochloride, blocks certain chemicals that affect the heart and this may stimulate the immune system and allow the chemotherapy to kill more tumor cells.
PRIMARY OBJECTIVES: I. To determine the feasibility of pharmacologic beta-adrenergic blockade in women with stages II-IV epithelial ovarian cancer patients (n=25) either during initial tumor reductive surgery and through the first six cycles of standard intravenous chemotherapy or during neoadjuvant chemotherapy followed by surgery and further chemotherapy (chemo) up to a total of 6 cycles. SECONDARY OBJECTIVES: I. To characterize the biobehavioral states of these patients by using the Functional Assessment of Chronic Illness and Therapy- Ovary (FACT-O), Hospital Anxiety and Depression Survey (HADS) and the Center for Epidemiologic Studies Depression Scale (CESD) and serum levels of angiogenic cytokines at points pre- and post-treatment with beta-blockers. II. To follow patients for progression-free survival (PFS) and overall survival (OS). TRANSLATIONAL OBJECTIVES: I. Determining vascular endothelial growth factor (VEGF), interleukin (IL)-6, IL-8, and other cytokines levels in patients with ovarian cancer who are receiving beta-blockers and comparing these levels pre-treatment and during treatment with response. OUTLINE: Patients receive propranolol hydrochloride orally (PO) twice daily (BID) beginning 48-72 hours before treatment. Patients undergoing surgery resume propranolol hydrochloride post-operatively once oral drugs are tolerated and continue until completion of 6 cycles of chemotherapy. Patients undergoing neoadjuvant chemotherapy continue propranolol hydrochloride PO BID during 3 chemotherapy cycles pre-surgery and 3 cycles post-surgery. Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Lyndon Baines Johnson General Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
The Woman's Hospital of Texas
Houston, Texas, United States
MD Anderson in Katy
Houston, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
MD Anderson in The Woodlands
The Woodlands, Texas, United States
Start Date
March 9, 2012
Primary Completion Date
August 15, 2019
Completion Date
August 15, 2019
Last Updated
August 29, 2019
32
ACTUAL participants
Chemotherapy
DRUG
Propranolol Hydrochloride
DRUG
Quality-of-Life Assessment
OTHER
Therapeutic Conventional Surgery
PROCEDURE
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT04919629
NCT01167712
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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