NAC to help with chemo-related thinking problems in ovarian cancer patients on platinum therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a combined phase I dose-escalation and phase II dose-expansion study to determine the maximum tolerated dose and safety of NAC when given with platinum-based chemotherapy. The trial will monitor safety, tolerability, and potential effects on chemotherapy-related cognitive impairment. Participants are post-menopausal women with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer who are planned for or have completed cytoreductive surgery and are receiving at least six cycles of platinum therapy. NAC or placebo will be administered in addition to standard treatment, with dose levels adjusted to establish MTD in phase I before expanding to more patients in phase II. Primary goals include safety and tolerability, with cognitive outcomes as a secondary focus.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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:

  1. Hemoglobin \> 9 g/dL
  2. Leukocytes \>1,500/mcl
  3. Absolute Neutrophil Count \> 1,000/mcL
  4. Platelets \> 125,00/mcL
  5. total bilirubin Within normal institutional limits
  6. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2.5 x institutional upper limit of normal
  7. Serum creatinine \< 1.5 mg/dL.

Exclusion Criteria:

* 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.

Where it's running

• Chao Family Comprehensive Cancer Center, University of California, Irvine
  Orange, California, United States Recruiting

Study contacts

• Principal investigator: Daniela Bota, MD, PhD — Chao Family Comprehensive Cancer Center
• Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
• Email: ucstudy@uci.edu
• Phone: 1-877-827-7883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.