Ovarian Cancer Clinical Trial
Phase 1 Dose Escalation of ArtemiCoffee
Summary
This is a phase I dose-escalation study of Artemisia annua (Aa) in patients with advanced ovarian cancer who have completed front-line chemotherapy with carboplatin and paclitaxel. The primary objective of this study is to determine the recommended phase II dose (RP2D) of Artemisia annua.
Full Description
This is a phase I dose-escalation study of Artemisia annua (Aa) decaffeinated coffee in patients with advanced ovarian cancer who have completed front-line chemotherapy with carboplatin and paclitaxel. The primary objective of this study is to determine the recommended phase II dose (RP2D) of Aa decaf coffee pods. Sequential cohorts of three patients per cohort will have escalating doses of Aa, starting with one cup per day (450mg) and with a maximum of 4 cups per day (1800mg). After identifying the RP2D, the study will evaluate an expansion cohort of 6 patients for further tolerability and secondary endpoints. The secondary endpoints include: 1) Efficacy as measured by time to tumor progression or recurrence; 2) the ability of Aa decaf coffee to influence downstream biomarkers of the NRF2/KEAP1 signaling pathway; and 3) plasma concentrations of artemisinin and dihydroartemisinin.
Eligibility Criteria
Inclusion Criteria:
Able to understand and willing to sign a written informed consent document.
Age ≥ 18 years.
Patients diagnosed with Stage II-IV ovarian cancer who have completed initial first-line therapy with carboplatin and paclitaxel and achieved a complete response.
Creatinine clearance ≥ 60 mL/min
Total bilirubin ≤ 1.5 x ULN, and AST and ALT ≤ 3.0 x ULN
GOG Performance Status ≤ 2.
Exclusion Criteria:
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study visits, in the opinion of the treating physician.
Pregnant women are excluded from this study.
Concurrent use of strong inducers of CYP2A6, including phenobarbital and rifampin
Women with active gastric ulcers are excluded from this study.
Patients who are receiving concurrent maintenance therapy with a PARP inhibitor for a known hereditary recombinant deficiency (HRD) mutation. Bevacizumab maintenance therapy is allowed.
Concurrent use of nevirapine, ritonavir and strong UGT inhibitors or inducers.
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