Our proposal is to conduct an open phase II clinical trial that allows us to explore the activity of ketoconazole, an inhibitor of the enzyme CYP17, in ovarian granulosa tumors similar to what has been done in prostate cancer. The rational is based on dysregulation that FOXL2 mutations present in almost all granulosa tumors result in the expression of CYP17 that appears to be key in the development and progression of the disease. This work would represent the first attempt to address the treatment of ovarian granulosa cancer with a molecular solid rational, drawing on the recent identification of the mutation "leader" of this tumor. If succeed provide a widely available therapeutic alternative compared with current cancer therapies, with low toxicity. In addition it would open a new line of research with CYP17 enzyme inhibitors that could alter the course and outcome, usually fatal, in advanced stages of disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Patients will receive ketoconazole, 400 mg three times a day. Study treatment period will be during 6 months or up to progression disease, unacceptable toxicity, death or withdraw from the study for any reason.
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Reina Sofía
Córdoba, Cordoba, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital Morales Meseguer
Murcia, Murcia, Spain
Complejo Hospitalario de Navarra
Navarra, Navarre, Spain
Hospital Son Llatzer
Palma de Mallorca, Palma de Mallorca, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain
Overall response rate
The primary endpoint is overall response rate, defined as the proportion of patients with response defined as complete or partial response according to RECIST CRITERIA 1.1 measured by an external evaluator
Time frame: Every 8 weeks
Clinical benefit
Clinical benefit defined as stable disease for more than 6 months plus complete and partial response rates, measured by an external evaluator.
Time frame: Every 8 weeks
Progression-free survival
Progression-free survival is defined as the time since the start of treatment until progressive disease assessed (through evaluation by an external radiologist) according to RECIST 1.1, or death by any cause.
Time frame: Every 8 weeks
Overall survival
Overall survival, defined as the time since the start of treatment until the patient dies by any cause.
Time frame: Untill death
Quality of life
Quality of life measured by the validated in Spanish EORTC QLQ-C30 questionnaire.
Time frame: Every 4 weeks
Safety profile
Toxicities will be classified according to the NCI-CTCAE v4.03
Time frame: Every 4 weeks
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