What side effects are associated with this type of intervention?

Common treatments for ovarian cancer that induce apoptosis and inhibit angiogenesis, such as bevacizumab and pazopanib, are associated with several side effects. Bevacizumab can cause hypertension, proteinuria, and an increased risk of thromboembolic events. Pazopanib is known for significant hypertension, diarrhea, and hepatotoxicity. Both treatments may also lead to cardiovascular and non-cardiovascular toxicities, which are critical considerations for patients.

What prior FDA approvals exist?

Several FDA-approved treatments for ovarian cancer focus on inducing apoptosis and inhibiting angiogenesis. Bevacizumab, an anti-angiogenic agent targeting VEGF, has been approved for use in combination with chemotherapy for advanced ovarian cancer. Additionally, PARP inhibitors like olaparib, niraparib, and rucaparib, which induce apoptosis in cancer cells with BRCA mutations, have also received FDA approval for maintenance therapy in recurrent ovarian cancer. These treatments share mechanisms similar to those being studied in the trial of Artemisia annua.

What other types of research exist?

Promising novel alternatives to Artemisia annua for ovarian cancer treatment include: 1) Magnolol, which induces apoptosis through intrinsic/extrinsic pathways and inhibits ERK/NF-κB signaling, 2) Anemone altaica extract, which suppresses cell viability in osteosarcoma cells and may have similar effects in ovarian cancer, and 3) Mistletoe extracts (Iscador), which have shown some anticancer activity, though evidence is mixed. These agents have demonstrated potential in inducing apoptosis and inhibiting tumor progression.

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Herbal Therapy

ArtemiCoffee for Ovarian Cancer

Phase 1

Waitlist Available

Led By Frederick Ueland, MD

Research Sponsored by Frederick R. Ueland, M.D.

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.

Must not have

Concurrent use of strong inducers of CYP2A6, including phenobarbital and rifampin

Concurrent use of nevirapine, ritonavir and strong UGT inhibitors or inducers.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 150 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special decaf coffee made from Artemisia annua in patients with advanced ovarian cancer who have finished chemotherapy. The goal is to see if this coffee can help delay tumor growth and affect cancer-related pathways.

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.

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.

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 below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not taking medications like phenobarbital or rifampin.

Select...

I am not taking nevirapine, ritonavir, or strong UGT affecting drugs.

Select...

I do not have an active gastric ulcer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 150 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~150 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 150 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recommended Phase II Dose

Secondary study objectives

Progression Free Survival

Other study objectives

Change in ABCF2 expression.

Change in CD99 expression.

Change in HO-1 expression.

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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).

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include chemotherapy, anti-angiogenic agents, and PARP inhibitors. Chemotherapy drugs like carboplatin and paclitaxel damage the DNA of cancer cells, leading to their death. Anti-angiogenic agents, such as bevacizumab, prevent the formation of new blood vessels that tumors need to grow. PARP inhibitors, like olaparib, block the PARP enzyme, hindering cancer cells' ability to repair DNA, resulting in cell death. Treatments like Artemisia annua, which induce apoptosis and inhibit angiogenesis, are significant as they promote cancer cell death and prevent tumor growth, offering a multi-faceted approach to combat ovarian cancer.

Aflibercept in epithelial ovarian carcinoma.