Phase 1 Dose Escalation of ArtemiCoffee

Frederick R. Ueland, M.D.13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

Artemisia annua 450mgDRUG

Artemisia annua will be self-administered via a preparation of decaffeinated coffee.

Artemisia annua 900mgDRUG

Artemisia annua will be self-administered via a preparation of decaffeinated coffee.

Artemisia annua 1350mgDRUG

Artemisia annua will be self-administered via a preparation of decaffeinated coffee.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Kentucky

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Recommended Phase II Dose

This study will determine the recommended phase II dose of Artemisia annua decaffeinated coffee. Once the dose escalation is finished or 12 patients are evaluated for the dose-limiting toxicity (DLT), the final recommended phase II dose will be determined by isotonic regression to pool the DLT information across all dose levels.

Time frame: 150 days

Secondary Outcomes

Progression Free Survival

Median progression free survival will be calculated for all groups.

Time frame: 150 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.