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Anti-tumor antibiotic

Combination of DOXIL and Ashwagandha 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study entry, up to 4 years.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My cancer can be measured or seen on tests.

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

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I am a woman aged 18 or older.

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

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

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

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Duration of response

Incidence of adverse events (AE)

Objective response rate (ORR)

+1 more

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

2017

Completed Phase 2

~140

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Louisville Health CareUNKNOWN

Sham Sunder KakarLead Sponsor

Whitney Goldsberry, MDPrincipal InvestigatorBrown Cancer Center at University of Louisville

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall count of individuals involved in this clinical research?

"Yes, the details on clinicaltrials.gov indicate that this clinical study is actively seeking candidates. The trial was initially published on May 1st, 2024, and received its latest update on April 22nd, 2024. Recruitment aims to enlist 72 individuals at a single site."

Answered by AI

Are there currently any available slots for new participants in this medical trial?

"Affirmative. Information available on clinicaltrials.gov affirms that this ongoing clinical trial is actively enlisting volunteers. The trial was initially listed on May 1, 2024 and last revised on April 22, 2024. Recruitment aims to secure the participation of a total of 72 individuals from one designated center."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Therapy for Recurrent Ovarian Cancer

Sham Sunder Kakar 2024. "Combination Therapy for Recurrent Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05610735.

All > Recurrent Ovarian Cancer