OncoMatch/Clinical Trials/NCT05610735
Combination Therapy for Recurrent Ovarian Cancer
Is NCT05610735 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including DOXIL and Withaferin A for recurrent ovarian cancer.
Treatment: DOXIL · Withaferin A · Ashwagandha · Combination of ASWD and DOXIL — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Disease stage
Grade: high grade papillary serous carcinomalow grade papillary serous carcinomahigh grade mucinous carcinomalow grade mucinous carcinomaclear cell carcinomahigh grade endometrioid carcinoma
with the one of the following histologic types: high grade papillary serous carcinoma, low grade papillary serous carcinoma, high grade mucinous carcinoma, low grade mucinous carcinoma, clear cell carcinoma, high grade endometrioid carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — first line
Cannot have received: liposomal doxorubicin
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^3/L, platelet count ≥ 100 x 10^3/L, hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L), patients may receive packed RBC transfusion to achieve this level at the discretion of the investigator
Kidney function
calculated creatinine clearance ≥ 60 mL/min per Cockcroft and Gault formula
Liver function
total bilirubin < 1.5 x ULN unless elevated secondary to conditions such as Gilbert's Disease, AST < 3 x ULN (< 5 x ULN in the presence of hepatic metastases), ALT < 3 x ULN (< 5 x ULN in the presence of hepatic metastases), alkaline phosphatase < 3.0 x ULN
Cardiac function
Adequate ejection fraction determined by transthoracic echo or MUGA of at least 55%
Adequate organ function within 14 days prior to first WFA/ASWD dose or liposomal doxorubicin whichever occurs first, including the following: absolute neutrophil count (ANC) ≥ 1.5 x 10^3/L, platelet count ≥ 100 x 10^3/L, hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L), patients may receive packed RBC transfusion to achieve this level at the discretion of the investigator, total bilirubin < 1.5 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert's Disease, aspartate aminotransferase (AST) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases), alanine aminotransferase (ALT) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases), alkaline phosphatase < 3.0 x ULN, calculated creatinine clearance ≥ 60 mL/min per Cockcroft and Gault formula; Adequate ejection fraction determined by transthoracic echo or MUGA of at least 55%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UofL Health Brown Cancer Center · Louisville, Kentucky
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