A Pilot Trial to Evaluate the Feasibility Auranofin (Ridaura®) for Asymptomatic Patients With First-Recurrence Epithelial Ovarian Cancer
I. To demonstrate the feasibility of conducting a 10-patient pilot study in asymptomatic
ovarian cancer patients with cancer antigen (CA 125) elevation.
I. To explore whether oral gold therapy either stabilizes or lowers the CA 125 level and
maintains patients in an asymptomatic state and to provide descriptive data on tumor
response and duration of response.
II. To acquire qualitative data on patients' perceptions of learning of CA 125 elevation.
III. To explore whether immunohistochemical staining for PKC iota expression in resected
tumor samples appears to be associated with clinical outcomes with auranofin.
Patients receive auranofin orally (PO) twice daily (BID) on days 1-28. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients using CA 125 elevation
To demonstrate the feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients with CA 125 elevation. This study could potentially serve as a paradigm to investigate agents that might eventually be used as maintenance therapy in patients at high risk for recurrent disease.
Up to 2 years
Aminah Jatoi, M.D.
United States: Institutional Review Board
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