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

• Status: Completed
• Trial end date: 2019-08-27
• Target enrollment: 0
• Participant gender: Female

Summary

This is a phase I/II study to find the highest dose of hydroxychloroquine that can be given safely with itraconazole in patients with advanced platinum-resistant epithelial ovarian cancer. The study will also determine the safety, tolerability, and initially determine whether the combination is useful in the treatment of patients with advanced platinum-resistant epithelial ovarian cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Hydroxychloroquine; Hydroxyitraconazole; Itraconazole

Criteria

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).