Ovarian Endometrioid Adenocarcinoma Clinical Trial
Official title:
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.
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