← Back to Search

Anti-tumor antibiotic

Ashwagandha + DOXIL for Ovarian Cancer

Phase 1 & 2

Recruiting

Led By Whitney Goldsberry, MD

Research Sponsored by Sham Sunder Kakar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have evaluable or measurable disease

ECOG performance status of 0, 1, or 2

Must not have

Previous treatment with liposomal doxorubicin

Patients with known pericardial effusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study entry, up to 4 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new treatment for recurrent ovarian cancer using a combination of Ashwagandha and liposomal doxorubicin (DOXIL). The study will determine the safe and

Who is the study for?

This trial is for women over 18 with recurrent ovarian cancer, including various subtypes, who've had at least two prior chemotherapy treatments (one platinum-based) and haven't been treated with liposomal doxorubicin. They should understand the study's experimental nature, have a life expectancy over six months, and measurable disease or elevated CA 125 levels.

What is being tested?

The study tests combining Ashwagandha (ASWD) in tablet form at different doses (2g, 4g, 8g) with DOXIL to find the safest high dose of ASWD. It will then assess how well this combination works to improve outcomes like complete response or stable disease in patients.

What are the potential side effects?

Potential side effects may include those commonly associated with DOXIL such as fatigue, nausea, hair loss and heart issues; plus any unknown risks from Ashwagandha which could range from digestive upset to allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer can be measured or seen on tests.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I am a woman aged 18 or older.

Select...

I've had chemotherapy with platinum and my cancer is now resistant to it.

Select...

My cancer has come back, confirmed by tests or high CA 125 levels.

Select...

My cancer originates from the ovary, fallopian tube, or peritoneum and has been confirmed by pathology.

Select...

My cancer did not respond or stopped responding to platinum-based chemotherapy.

Exclusion Criteria

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

Select...

I have been treated with liposomal doxorubicin before.

Select...

I have fluid around my heart.

Select...

I have a condition that causes active bleeding.

Select...

I am on medication that affects my heart's electrical activity.

Select...

I have previously used anthracyclines or anthracenediones.

Select...

I am mostly bedridden due to my health condition.

Select...

I have heart issues like heart failure, unstable chest pain, or a recent heart attack.

Select...

I have brain metastases, treated or not.

Select...

I do not have any serious infections or health conditions that would interfere with the study.

Select...

I have or had cancer other than ovarian cancer.

Select...

I am not currently taking any other cancer medications.

Select...

I do not have severe infections, septicemia, or acute hepatitis.

Select...

I have a serious heart lining condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study entry, up to 4 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study entry, up to 4 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study entry, up to 4 years. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Duration of response

Incidence of adverse events (AE)

Objective response rate (ORR)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination of DOXIL and AshwagandhaExperimental Treatment4 Interventions

The study contains two parts. In part 1 (Phase I), 18 patients with recurrent ovarian cancer will be recruited and administered IV with liposomal doxorubicin (DOXIL) 40 mg/m2 on day 1 of 28 days cycle for 4 cycles. Ashwagandha will be administered on daily basis for 2 years. Three doses of Ashwagandha (2 g, 4 g or 8.0 g) will be administered orally with water every day for two years to evaluate a tolerable dose of Ashwagandha. Six patients will be recruited for each dose. In part 2 Phase II), 54 additional patients with recurrent ovarian cancer will be recruited and administered with DOXIL IV (40 mg/m2) and maximum tolerable dose of Ashwagandha (determined from part 1) in the form tables orally with water on daily basis for two years. The survival rate (SR), complete response (CR) and partial response (PR) will be evaluated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DOXIL

2005

Completed Phase 3

~2240

Ashwagandha

2024

Completed Phase 2

~170