Phase I Dose-Escalating and Phase II Dose-Expansion Study of N-Acetyl-Cysteine (NAC) Administration to Ovarian Cancer Patients Receiving Platinum-Based Therapy (PBT) for the Mitigation of Chemotherapy-Related Cognitive Impairment (CRCI)
This is a phase I, dose-escalation and phase II dose-expansion clinical trial determining the maximum tolerated dose (MTD) and safety and tolerability of adding N-Acetyl-Cysteine (NAC) to ovarian cancer patients who are receiving a platinum-based therapy (PBT). This study will investigate whether NAC will mitigate chemotherapy-related cognitive impairment (CRCI).
∙ Post-menopausal females (as defined by lack of menstruation for 12 months or status post oophorectomy)
• Histologic or pathologic diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer
• Eastern Cooperative Oncology Group (ECOG) ≤2
• Life expectancy \> 1 year
• Status post cytoreductive surgery for ovarian cancer or with planned cytoreductive surgery if treated with neoadjuvant chemotherapy
• Prescribed a minimum of six cycles of platinum-based chemotherapy
• Adequate organ function as defined below:
‣ Hemoglobin \> 9 g/dL
⁃ Leukocytes \>1,500/mcl
⁃ Absolute Neutrophil Count \> 1,000/mcL
⁃ Platelets \> 125,00/mcL
⁃ total bilirubin Within normal institutional limits
⁃ Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2.5 x institutional upper limit of normal
⁃ Serum creatinine \< 1.5 mg/dL.