Actively Recruiting
Combination Therapy With Liposomal Doxorubicin and Withaferin A (Ashwagandha) in Recurrent Ovarian Cancer
Led by Sham Sunder Kakar · Updated on 2026-03-19
72
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Sham Sunder Kakar
Lead Sponsor
U
University of Louisville
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the combination of liposomal doxorubicin (DOXIL) and Ashwagandha (Withaferin A, ASWD) in patients with recurrent ovarian cancer to determine the safe and tolerable dose of Ashwagandha alongside DOXIL. This trial includes two phases: Phase I focuses on dose escalation and safety with 18 patients, and Phase II evaluates treatment response in 54 patients using the dose identified in Phase I. The study aims to understand the effectiveness and safety of this combined therapy in managing recurrent ovarian cancer. In Phase I, participants receive DOXIL intravenously every 4 weeks for up to 10 cycles or until disease progression or unacceptable toxicity occurs. Ashwagandha is given orally twice daily at escalating doses (2.0 g, 4.0 g, or 8.0 g per day) to find the maximum tolerated dose. In Phase II, patients will be treated with DOXIL plus the Ashwagandha dose identified in Phase I, continuing for up to 10 cycles or until progression or toxicity. After DOXIL treatment ends, Ashwagandha may be continued daily as maintenance therapy. Participants undergo regular assessments including blood tests (complete blood count, liver function, coagulation), imaging studies, and biomarker analysis to monitor treatment effects and side effects. Researchers measure progression-free survival, response rates, and overall survival up to four years. Safety is closely monitored using standardized criteria for adverse events. Participants are followed throughout treatment and for long-term outcomes, with the study lasting up to two years of treatment and additional follow-up.
CONDITIONS
Brief Title
Combination Therapy for Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Diagnosed with recurrent ovarian, fallopian tube, or primary peritoneal cancer with specific histologic types
- Received at least one platinum-containing chemotherapy and developed platinum resistance or refractory disease
- Eligible for liposomal doxorubicin treatment
- May have undergone surgical cytoreduction or not
- Recurrent disease confirmed by biopsy, imaging, or elevated CA 125
- May have received radiation therapy
- Life expectancy greater than 6 months
- For Phase 1: evaluable disease by radiologic measurements or CA 125
- For Phase 2: measurable disease with lesions at least 1 cm by CT or 2 cm by standard techniques
- Adequate organ function including blood counts, liver and kidney function
- Non-pregnant and non-lactating females with reliable contraception if of reproductive potential
- Able and willing to comply with study visits and procedures
- Discontinued prior cancer therapies for at least 4 weeks before study treatment in Phase 1
- ECOG performance status of 0, 1, or 2
- Adequate heart function with ejection fraction at least 55%
- Prior anthracycline or anthracenedione therapy allowed with cumulative dose considerations
You will not qualify if you...
- ECOG performance status of 3 or 4
- Pregnant or breastfeeding
- Treatment with another investigational drug or biological agent within 4 weeks (6 weeks for biologics) before screening
- Known brain metastases or leptomeningeal disease
- Known pericardial effusion or clinically significant pericardial disease
- Active infection or serious systemic disorder incompatible with the study
- History of other malignancies unless treated over 2 years ago without recurrence
- Underlying bleeding disorders
- Concurrent treatment with other anticancer drugs
- Participation in another clinical trial with experimental agents
- Medical conditions making participation unsuitable
- Septicemia, severe infection, or acute hepatitis
- Congestive heart failure, unstable angina, or recent myocardial infarction within 6 months
- Taking medications affecting cardiac conduction
- Allergy to withaferin A or Ashwagandha
- Previous treatment with liposomal doxorubicin or other anthracyclines or anthracenediones without meeting cumulative dose criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 cycles of 4 weeks each (approximately 40 weeks), or until disease progression or unacceptable toxicity
Participants receive liposomal doxorubicin (DOXIL) intravenously every 4 weeks combined with oral Ashwagandha (ASWD) taken twice daily. DOXIL treatment lasts for at least 4 cycles and up to a maximum of 10 cycles or until disease progression or unacceptable toxicity occurs. Ashwagandha is started on day 1 of the first DOXIL cycle and continues daily during treatment.
IV infusion visits every 4 weeks; daily oral medication; weekly laboratory visits during first cycle, then prior to each infusion
Duration - Up to 2 years or until disease progression or unacceptable toxicity
After completion of DOXIL treatment, participants continue daily Ashwagandha as maintenance therapy until disease progression or unacceptable toxicity. Participants are monitored for long-term outcomes including survival and response.
Regular follow-up visits as determined by the provider
Trial Site Locations
Total: 1 location
1
UofL Health Brown Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
S
Sham Kakar, PhD
W
Whitney Goldsberry, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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