This phase I trial is to determine the best dose, possible benefits and/or side effects of Artemisia annua decaffeinated (decaf) coffee in treating patients with stage II-IV ovarian cancer who have completed front-line cytoreductive surgery and chemotherapy. Artemisia annua is an herb traditionally used to treat fever, inflammation, and malaria. Ovarian cancer cells may be sensitive to Artemisia annua. Giving Artemisia annua decaf coffee may prevent cancer from coming back (recurrence) in patients with ovarian cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04805333.
PRIMARY OBJECTIVE:
I. To determine the recommended phase II dose of Artemisia annua (Aa) decaf coffee.
SECONDARY OBJECTIVE:
I. To determine the efficacy of Aa decaf coffee as measured by progression-free survival.
BIOMARKER EXPLORATORY OBJECTIVES:
I. To determine the ability of the Aa decaf coffee to influence downstream biomarkers of the NRF2/KEAP1 signaling pathway.
II. To assess the plasma concentrations of Artemisinin and dihydroartemisinin.
QUALITATIVE RESEARCH OBJECTIVES:
I. To evaluate patient perspectives of Aa decaf coffee's use of Kentucky-grown ingredients.
II. To determine how patient life experiences may impact perspectives on Aa decaf coffee.
OUTLINE: This is a dose-escalation study of Artemisia annua decaf coffee.
Four weeks after the last day of cycle 6 standard of care chemotherapy, patients receive Artemisia annua decaf coffee PO on days 1-30. Treatments repeat every 30 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients attend interviews over 1 hour after 1 week of Aa decaf coffee consumption and again after 5 cycles. Additionally, patients undergo blood sample collection on study.
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationUniversity of Kentucky/Markey Cancer Center
Principal InvestigatorFrederick Rand Ueland
