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).