Combination Therapy for Recurrent Ovarian Cancer
Eligible age
18+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
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).
Sponsor: Sham Sunder Kakar
You may qualify if…
- ✓ Patients with recurrent ovarian/fallopian tube/primary peritoneal cancer for whom liposomal Doxorubicin would be an acceptable therapeutic option will be recruited. Patients are eligible if they have received first line chemotherapy containing platinum and have become platinum resistance or have refractory disease. The patient must also meet all the following criteria:
- ✓ 1. Signed approved informed consent document stating that they understand the investigational nature of the treatment program before entering study
- ✓ 2. Female patients, age ≥ 18 years
- ✓ 3. Pathological confirmed ovarian, fallopian tube, or primary peritoneal 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.
- ✓ 4. Received at least one line chemotherapy, which must be a platinum containing regimen and develop platinum resistance. Patients may have not received previous liposomal doxorubicin therapy, and must be considered to be eligible for single agent liposomal doxorubicin treatment.
- ✓ 5. Patients may have undergone surgical cytoreduction at the time of primary diagnosis or following neoadjuvant chemotherapy. Patients who had optimal (\<1 cm residual disease) or suboptimal (\>1 cm residual disease) following surgical cytoreduction will be included.
- ✓ Patients who did not undergo surgical cytoreduction will also be included.
- ✓ 6. Recurrent disease confirmed by biopsy, radiologic imaging, and/or elevated CA 125
You may not qualify if…
- ✕ Patients will be excluded from the study if they meet any of the following criteria:
- ✕ 1. ECOG performance status 3 or 4
- ✕ 2. Pregnant or breastfeeding
- ✕ 3. Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening or 5 half-lives of study agent, whichever is longer
- ✕ 4. Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is required for symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients
- ✕ 5. Patients with known pericardial effusion
- ✕ 6. Patients with active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the Investigator)
- ✕ 7. Presence or history of malignancy other than ovarian cancer that does not include carcinoma in situ of the cervix, or non-melanoma skin cancer. In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least two years previously with no subsequent evidence of recurrence
Where it's recruiting
Louisville
Source: ClinicalTrials.gov · NCT05610735 · last updated 2026-03-19