Recurrent Ovarian Epithelial Cancer Clinical Trial
Official title:
The Use and Safety of Metformin, Carboplatin and Paclitaxel in Non-Diabetic Patients With Recurrent, Platinum Sensitive Ovarian Cancer and the Feasibility of Using a Core Biopsy for RNA-Seq
This phase I trial studies the side effects and best way to give metformin hydrochloride, carboplatin, and paclitaxel in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as metformin hydrochloride, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVES:
I. To determine the duration of response to metformin (metformin hydrochloride), carboplatin
and paclitaxel followed by maintenance with metformin as compared to the primary duration of
remission in within patient controls.
SECONDARY OBJECTIVES:
I. Determine the in situ effects of metformin on lethal-7 (let-7) expression as determined by
in situ hybridization. (Phase Ia) II. To determine the feasibility of using a core biopsy to
perform ribonucleic acid (RNA) sequencing. (Phase Ia) III. To determine epigenomic effects of
metformin via RNA-sequencing (Seq). (Phase Ia) IV. To determine the biologic effects of
metformin through evaluation of pre and post metformin tumor samples for phosphorylated (p)
adenosine monophosphate (AMP)-activated protein kinase (AMPK), v-myc myelocytomatosis viral
oncogene homolog (avian) (myc), mechanistic target of rapamycin (mTOR) and phosphorylated
v-akt Murine Thymoma Viral Oncogene Homolog 1 (pAKT). (Phase Ia) V. To assess safety and
tolerability of metformin and carboplatin and paclitaxel in patients with platinum sensitive
recurrent ovarian cancer. (Phase Ib)
OUTLINE:
Phase Ia: Patients receive metformin hydrochloride orally (PO) once daily (QD) on days 1-7
and twice daily (BID) on days 8-21.
Phase Ib: Patients receive metformin hydrochloride BID on days 1-21, paclitaxel intravenously
(IV) over 3 hours on day 1, and carboplatin IV over 30 minutes on day 1. Treatment repeats
every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks.
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