Combination Therapy for Recurrent Ovarian Cancer

This study is looking at a combination treatment for recurrent ovarian cancer. It's testing DOXIL (a chemotherapy drug given through an IV) with Ashwagandha (a natural supplement taken by mouth). The main goal is to see how long people live without their cancer getting worse (called progression-free survival). You might be able to join if you have recurrent ovarian, fallopian tube, or primary peritoneal cancer, and your cancer has become resistant to platinum-based chemotherapy. The study is currently unclear about its recruitment status, but plans to enroll 72 participants. The first part of the study will focus on finding the right dose of Ashwagandha that can be safely given with DOXIL.

Study design: This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It will enroll about 72 participants and has two parts, with the first part focusing on feasibility and tolerability.
What's involved: You would receive DOXIL through an IV every four weeks and take Ashwagandha tablets by mouth daily. This treatment would continue for at least 4 cycles, or up to 10 cycles, or until your disease progresses or side effects become too much.
Compensation: Not stated in the trial record.
Follow-up: Your progression-free survival will be measured from when you start the study until your disease progresses or you pass away, for up to 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Combination Therapy for Recurrent Ovarian Cancer

Recruiting

PHASE1Ages 18+InterventionalTreatment

Sham Sunder Kakar

~72 participants

Updated 2026-03-19 on ClinicalTrials.gov

What's tested:DOXILWithaferin AAshwagandhaCombination of ASWD and DOXIL

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Progression-free survival (PFS)

Measured over From study entry to time of progression or death, whichever occurs first, assessed up to 4 years.

Conditions

Recurrent Ovarian Cancer

Where it's being run

1 sites across 1 states

Kentucky1

Study leadership

Whitney Goldsberry, MD · PRINCIPAL_INVESTIGATOR · Brown Cancer Center at University of Louisville

Who to contact

Sham Kakar, PhD

[email protected]

(502) 931-1485

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Females: non-pregnant and non-lactating; surgically sterile, post- menopausal, or patient/partner compliant with a reliable contraceptive regimen, as determined by the investigator, for 4 weeks prior to screening.

Patients of reproductive potential must test negative for pregnancy at screening, prior to each cycle, and must agree to use a reliable method of birth control during the study period and 6 months following completion of treatment. 13. The patient is willing and able to comply with the study visit schedule and procedures and has geographical proximity (Investigator's discretion) that allows follow-up specified by the protocol 14. For Part 1: Patients have discontinued all prior chemotherapies, biological therapies, and other investigational therapies for cancer for at least 4 weeks prior to study treatment and have recovered from the acute effects of therapy 15. ECOG performance status of 0, 1, or 2 16. Adequate ejection fraction determined by transthoracic echo or MUGA of at least 55% 17. Patients may have received prior anthracycline or anthracenedione therapy. In this scenario, the use of prior treatments will be incorporated into the cumulative dose calculations when applicable, given a known increased risk of cardiomyopathy to 11% when the cumulative dose of liposomal doxorubicin was between 450 mg/m2 to 550 mg/m2.

What this trial measures

Progression-free survival (PFS)From study entry to time of progression or death, whichever occurs first, assessed up to 4 years.
Will be presented by Kaplan Meier methods.

Trialytics