Combination Therapy for Recurrent Ovarian Cancer

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Sham Sunder Kakar
Study ID
NCT05610735
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Recurrent Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DOXIL — DRUG
    DOXIL will be administered IV as 40 mg/m2 IV every four weeks for 4 cycles or until disease progression and/or unacceptable toxicity, whichever comes first to a maximum of 10 cycles.
  • Withaferin A — DRUG
    Ashwagandha in the form of tablets will be administered orally on daily basis.
  • Ashwagandha — DRUG
    Administered orally on daily basis twice a day
  • Combination of ASWD and DOXIL — DRUG
    DOXIL administered IV once every four weeks. ASWD administered orally on daily basis, twice a day.

Study Details

The proposed study "combination therapy with liposomal doxorubicin and withaferin A (Ashwagandha, ASWD) in recurrent ovarian cancer" is focused to determine the feasibility and maximum tolerance dose of Ashwagandha with liposomal doxorubicin (DOXIL) in recurrent ovarian cancer patients. The study contains two parts. In part 1 (phase I), 18 patients with recurrent ovarian cancer eligible for DOXIL therapy will be recruited and three doses of Ashwagandha (2.0 g, 4.0 g and 8.0 g) in the form of tablets along with DOXIL will be evaluated for feasibility and tolerance of ASWD. In part 2 (phase II), 54 patients with recurrent ovarian cancer will be recruited and treated with DOXIL and Ashwagandha (dose determined from part 1) to evaluate the complete response (CR), partial response (PR), and stable disease (SD).

Key Dates

Start date
Sep 25, 2024
Status verified
Mar 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of DOXIL and Ashwagandha
    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.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From study entry to time of progression or death, whichever occurs first, assessed up to 4 years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UofL Health Brown Cancer CenterLouisvilleKentucky40202
Whitney Goldsberry, MD
[email protected]
502-562-4370
Sham Kakar, PhD, MBA
[email protected]
502-852-0812
Whitney Goldsberry, MD (PRINCIPAL_INVESTIGATOR)
Sarah Todd, MD (SUB_INVESTIGATOR)

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By research site
UofL Health Brown Cancer Center· Louisville, KY

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