A Study of the Safety, Tolerability and Effectiveness of Hydroxychloroquine and Itraconazole in Platinum-resistant Epithelial Ovarian Cancer

This is an interventional treatment trial for Platinum-resistant Epithelial Ovarian Cancer Read More

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).