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Herbal Therapy
ArtemiCoffee for Ovarian Cancer
Phase 1
Recruiting
Led By Jill Kolesar, PharmD
Research Sponsored by Jill M Kolesar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients diagnosed with Stage II-IV ovarian cancer who have completed initial first-line therapy with carboplatin and paclitaxel and achieved a complete response.
GOG Performance Status ≤ 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 150 days
Awards & highlights
Study Summary
This trial is testing a possible new treatment for ovarian cancer. The goal is to find the best dose of the new treatment.
Who is the study for?
This trial is for adults over 18 with advanced ovarian cancer who've finished initial chemo with carboplatin and paclitaxel and are in complete response. They must have good organ function, not be pregnant, avoid certain drugs that affect liver enzymes or immune responses, and can't have uncontrolled illnesses or be on specific maintenance therapies.Check my eligibility
What is being tested?
The study tests different doses of Artemisia annua (Aa) to find the safest and most effective dose for phase II trials. Patients will receive escalating doses starting from 450mg up to a maximum of 1800mg to determine which one works best without causing severe side effects.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions to herbal supplements such as digestive discomfort, allergic reactions, or interactions with other medications. Close monitoring will identify any adverse effects related to the increasing doses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Stage II-IV ovarian cancer, finished my first treatment with carboplatin and paclitaxel, and my cancer is now undetectable.
Select...
I can perform all self-care but cannot work.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 150 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~150 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase II Dose
Secondary outcome measures
Progression Free Survival
Other outcome measures
Change in ABCF2 expression.
Change in CD99 expression.
Change in HO-1 expression.
+3 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Dose Expansion - Recommended Phase II DoseExperimental Treatment1 Intervention
This cohort will be an expansion of 6 patients for further tolerability and secondary endpoints analysis. They will consume the recommended phase II dose (dependent on prior analysis).
Group II: Dose 5 - 1800mg Artemisia annuaExperimental Treatment1 Intervention
Participants in this group will consume 4 cups of decaffeinated coffee (1800 mg Artemisia annua).
Group III: Dose 3 - 1350mg Artemisia annuaExperimental Treatment1 Intervention
Participants in this group will consume 3 cups of decaffeinated coffee (1350 mg Artemisia annua).
Group IV: Dose 2 - 900mg Artemisia annuaExperimental Treatment1 Intervention
Participants in this group will consume 2 cups of decaffeinated coffee (900 mg Artemisia annua).
Group V: Dose 1 - 450mg Artemisia annuaExperimental Treatment1 Intervention
Participants in this group will consume 1 cup of decaffeinated coffee (450 mg Artemisia annua).
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Jill M KolesarLead Sponsor
3 Previous Clinical Trials
515 Total Patients Enrolled
ArtemiLifeUNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
Jill Kolesar, PharmDPrincipal InvestigatorUniversity of Kentucky
3 Previous Clinical Trials
357 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your total bilirubin, AST, and ALT levels are within a certain range.I have Stage II-IV ovarian cancer, finished my first treatment with carboplatin and paclitaxel, and my cancer is now undetectable.I am not taking medications like phenobarbital or rifampin.Your kidneys work well enough to filter out waste products from your blood.I am not taking nevirapine, ritonavir, or strong UGT affecting drugs.I do not have an active gastric ulcer.I am on a PARP inhibitor for an inherited gene mutation, or I am receiving bevacizumab maintenance therapy.I can perform all self-care but cannot work.I am 18 years old or older.I do not have any serious illnesses that my doctor thinks could interfere with the study.
Research Study Groups:
This trial has the following groups:- Group 1: Dose 1 - 450mg Artemisia annua
- Group 2: Dose 3 - 1350mg Artemisia annua
- Group 3: Dose 5 - 1800mg Artemisia annua
- Group 4: Dose Expansion - Recommended Phase II Dose
- Group 5: Dose 2 - 900mg Artemisia annua
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current patient count for this investigation?
"Affirmative. The clinicaltrials.gov website states that the recruitment process for this medical trial, which was posted on March 26th 2021, is still ongoing. Only 18 participants are required and they will all be evaluated at a single site."
Answered by AI
Is this experiment actively searching for participants?
"Correct. The details available on clinicaltrials.gov indicates that this trial, initially published on March 26th 2021, is still actively recruiting patients. In total 18 participants need to be recruited from 1 medical facility."
Answered by AI
Has the FDA issued any authorization for Artemisia annua in dosages of 450mg?
"Since Artemisia annua 450mg is still in its first phase of clinical trials, there is restricted evidence to support safety and efficacy. Therefore, our team gave it a score of 1 out of 3 on the safety scale."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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