RecruitingPhase 1Phase 2NCT05610735

Combination Therapy for Recurrent Ovarian Cancer

Combination Therapy With Liposomal Doxorubicin and Withaferin A (Ashwagandha, ASWD) in Recurrent Ovarian Cancer

Sponsor

Sham Sunder Kakar

Enrollment

72 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

Recurrent Ovarian Cancer

Summary

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).

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug combination for women with recurrent ovarian, fallopian tube, or primary peritoneal cancer that has become resistant to platinum-based chemotherapy. It is for women whose cancer has returned and for whom liposomal doxorubicin (a type of chemotherapy) would be an appropriate treatment option. **You may be eligible if...** - You are a woman aged 18 or older - You have recurrent ovarian, fallopian tube, or peritoneal cancer confirmed by pathology - You have received first-line platinum-based chemotherapy and your cancer is now platinum-resistant or refractory - You are able to give informed consent **You may NOT be eligible if...** - You have not had prior platinum-based chemotherapy - Your cancer is still responsive to platinum therapy - You have poor organ function or other health conditions that may interfere with treatment (check with your doctor) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDOXIL

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.

DRUGWithaferin A

Ashwagandha in the form of tablets will be administered orally on daily basis.

DRUGAshwagandha

Administered orally on daily basis twice a day

DRUGCombination of ASWD and DOXIL

DOXIL administered IV once every four weeks. ASWD administered orally on daily basis, twice a day.

Locations(1)

UofL Health Brown Cancer Center

Louisville, Kentucky, United States

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NCT05610735

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