Combination Therapy for Recurrent Ovarian Cancer

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),

Trial Details

NCT ID
NCT05610735
Phase
PHASE1 / PHASE2
Sponsor
Sham Sunder Kakar
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • DOXIL
  • Withaferin A
  • Ashwagandha
  • Combination of ASWD and DOXIL
Locations (sample)
  • Louisville, Kentucky, United States|38.25424,-85.75941

Key Eligibility Criteria

  • Patients with recurrent ovarian/fallopian tube/primary peritoneal cancer for whom liposomal Doxorubicin would be an acceptable therapeutic option w…
  • Signed approved informed consent document stating that they understand the investigational nature of the treatment program before entering study
  • Female patients, age ≥ 18 years
  • Pathological confirmed ovarian, fallopian tube, or primary peritoneal carcinoma with the one of the following histologic types: high grade papillar…

For full eligibility, visit ClinicalTrials.gov.

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