Summary

Eligibility
for females ages 18 years and up (full criteria)
Dates
study started
estimated completion
Principal Investigator
by Daniela A. Bota

Description

Summary

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).

Official Title

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)

Keywords

Ovarian Cancer Cognitive Impairment Chemotherapy-Related Cognitive Impairments Ovarian Neoplasms Carcinoma, Ovarian Epithelial Cognitive Dysfunction Acetylcysteine N-monoacetylcystine N-Acetyl-Cysteine

Eligibility

You can join if…

Open to females ages 18 years and up

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.

You CAN'T join if...

  • Prior history of any cancer (other than non-melanoma skin cancer)
  • Chemotherapy, radiation therapy, or erythropoietin treatment within the last 6 months
  • Prior severe head injury
  • Has a history of dementia or other neurodegenerative disorders
  • Has an uncontrolled, treatment-resistant depression or other severe psychiatric illnesses
  • Presence of known brain metastases
  • Has an active infection requiring treatment
  • Known immunosuppressive disease
  • Has active systemic autoimmune diseases such as lupus
  • Receipt of systemic immunosuppressive therapy
  • Known human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
  • Pregnant of breastfeeding.

Lead Scientist at UC Irvine

  • Daniela A. Bota
    Associate Professor, Neurology. Authored (or co-authored) 73 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT04520139
Phase
Phase 1/2
Study Type
Interventional
Last Updated