| Eligibility |
Inclusion Criteria:
- Aged 18 years or older.
- Histologically or cytologically confirmed epithelial ovarian cancer.
- Platinum-resistant or refractory disease defined as a radiological or clinical
progression less than six months after having finished platinum-based chemotherapy.
- ECOG performance status equal to or less than 1.
- Have clinically or radiographically documented measurable disease.
- All systemic therapy must have been completed 4 weeks or greater prior to enrollment
with radiologic evidence of radiological disease progression.
- Life expectancy should be more than 3 months.
- Receiving any medications or substances that are inhibitors or inducers of CYP3A4 are
ineligible.
- Acceptable laboratory requirements within 7 days prior to enrollment
- Treated and asymptomatic brain metastases are eligible. Patients that received
palliative radiation (for brain metastases) are eligible if they have been
asymptomatic for at least 2 weeks with use of maintenance steroid therapy, and last
received radiation at least 4 weeks prior to start of therapy.
- Have the ability to understand and willing to sign a written informed consent
document.
Exclusion Criteria:
- Have not recovered (grade 1 or less) from adverse events related to previous
treatments are excluded with the exception of alopecia and lymphopenia. Peripheral
sensory neuropathy must be at grade 2 or less.
- Have any other prior malignancy from which the patient has been disease free for less
than 3 years, with the exception of adequately treated and cured basal or squamous
cell skin cancer, superficial bladder cancer, carcinoma in situ of any site or any
other cancer.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to itraconazole or hydroxychloroquine.
- Known G6PD deficiency due to the risk of hemolytic anemia with the use of
hydroxychloroquine.
- Known retinopathy due to the risk of worsening retinopathy with hydroxychloroquine.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic or asymptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements.
- Chronic Hepatitis B or hepatitis C infections should be excluded because of potential
effects on hepatic function and/ or drug interactions.
- Human Immunodeficiency Virus (HIV) infection.
- Already have a clinical indication for treatment with itraconazole (e.g. chronic
candidiasis or other fungal infection) or hydroxychloroquine (e.g. lupus).
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