Recurrent Ovarian Carcinoma Clinical Trial
Official title:
Evaluation of the Addition of N-Acetylcysteine to Topotecan in the Tumor Microenvironment of Persistent or Recurrent High Grade Endometrioid or Serous Ovarian Carcinoma
This randomized phase II trial studies the effects of acetylcysteine and topotecan hydrochloride on the tumor microenvironment, or cells that make up a tumor, compared to topotecan hydrochloride alone in patients with ovarian, fallopian tube, or primary peritoneal cancer that has not responded to treatment (persistent) or has returned after a period of improvement (recurrent) and is high grade (likely to grow and spread quickly). Research has shown that cancer cells may be able to convert nearby normal cells into cancer cells. Acetylcysteine may stop this from happening. Topotecan hydrochloride is a chemotherapy drug used to treat ovarian cancer, and may help acetylcysteine work better. This trial studies the effect of acetylcysteine and topotecan hydrochloride on the tumor microenvironment to see if they can help make it more difficult for tumor cells to grow.
PRIMARY OBJECTIVES:
I. To estimate the proportion of subjects with persistent or recurrent high grade
endometrioid or serous ovarian carcinoma who demonstrate a downregulation of monocarboxylate
transporter 4 (MCT4) in the ovarian stroma in response to exposure to topotecan (topotecan
hydrochloride) and N-acetylcysteine (NAC) (acetylcysteine) as compared to topotecan alone.
SECONDARY OBJECTIVES:
I. To determine the expression levels of caveolin 1 (Cav-1), solute carrier family 16
(monocarboxylate transporter), member 1 (MCT1), translocase of outer mitochondrial membrane
20 homolog (yeast) (TOMM20), fatty acid binding protein 4, adipocyte (FABP4), hypoxia
inducible factor 1, alpha subunit (HIF-1 alpha) and NF kappaB activating protein (NFκB) in
pathological samples of tumors after therapy with NAC relative to samples taken at time of
initial diagnosis.
II. To assess the potential impact of NAC on progression free survival, overall survival,
objective tumor response- complete or partial, and duration of response.
III. To estimate the proportion of subjects who survive progression free for at least 6
months and the proportion of patients who have objective tumor response, complete or partial
in response to therapy IV. To assess safety and tolerability of NAC plus topotecan treatment
in subjects with endometrioid or serous ovarian carcinoma by Common Terminology Criteria for
Adverse Events (CTCAE) version (v)4.0 criteria.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1,
8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
ARM II: Patients receive topotecan hydrochloride as in Arm I. Patients also receive
acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each
treatment day) and acetylcysteine orally (PO) twice daily (BID) on days 2-7, 9-14, 16-21, and
23-28, unless administration window was utilized. Courses repeat every 28 days in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 24 months.
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