Combination Therapy With Liposomal Doxorubicin and Withaferin A (Ashwagandha, ASWD) in Recurrent Ovarian Cancer
Sham Sunder Kakar
Summary
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).
Description
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. In both parts, ASWD will be administered orally daily whereas liposomal doxorubicin will be administered intravenously (IV) every 4 weeks for a…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 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 confirm…
Interventions
- DrugDOXIL
DOXIL will be administered IV as 40 mg/m2 IV every four weeks for 4 cycles or until disease progression and/or unacceptable toxicity, whichever comes first to a maximum of 10 cycles.
- DrugWithaferin A
Ashwagandha in the form of tablets will be administered orally on daily basis.
- DrugAshwagandha
Administered orally on daily basis twice a day
- DrugCombination of ASWD and DOXIL
DOXIL administered IV once every four weeks. ASWD administered orally on daily basis, twice a day.
Location
- UofL Health Brown Cancer CenterLouisville, Kentucky