Ashwagandha (Withaferin A) + Liposomal Doxorubicin

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

Administered orally on daily basis twice a day

Study Design Overview: This is a two-part open-label clinical trial of ASWD (Ashwagandha) administered to patients with recurrent ovarian cancer in combination with liposomal doxorubicin, (DOXIL) following at least one previous line of chemotherapy. Patients will initially be enrolled in part 1 of the study, which is the feasibility/tolerability evaluation. Once the part 1 enrollment is completed, the patients will be enrolled in part 2 of the 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.

Registro actualizado en ClinicalTrials.gov →

• 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 papillary serous carcinoma, low grade papillary serous carcinoma, high grade mucinous carcinoma, low grade mucinous carcinoma, clear cell carcinoma, high grade endometrioid carcinoma.
• 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.
• 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.

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.