Trial Information

Phase II Study of the Combination Carboplatin Plus Celecoxib in Heavily Pre-treated Recurrent Ovarian Cancer Patients

This phase II prospective study will be conducted at the Gynecologic Oncology Units of the
Catholic University of Rome and Campobasso, Italy. The study is non-sponsored, investigators
initiated. The primary objective is to determine the tumor response rate by RECIST criteria.
Secondary objectives included duration of response, progression-free survival (PFS), overall
survival (OS), toxicity assessment, and QoL measures.Patients are required to take celecoxib
(200 mg tablets by mouth twice daily, day 1 to 28), associated to intravenous carboplatin
(area under the curve (AUC) 5 over 30 to 60 minutes, every 28 days). Patients who will
develop carboplatin hypersensitivity reaction (HSR) will follow a desensitization protocol,
or alternatively will switch to cisplatin. Erythropoietic stimulating agent and myeloid
growth factors are not permitted for cycle 1 of study treatment, and their use will be
chosen by the treating physician, according to hospital policy.Treatment will be
discontinued when any of the following events occurs: radiographic or clinical evidence of
cancer progression; deterioration of health or intolerable toxicity; patient refusal. Before
starting treatment, patients will be evaluated by medical history, physical examination,
cell blood count (CBC), chemistry panel, Ca125, and either computed tomography or magnetic
resonance imaging scan. The primary endpoint is to determine the overall response (OR) rate.
Secondary endpoints include the assessment of duration of response, PFS, OS, toxicity events
and QoL scores. When treatment will be discontinued, patients will receive a follow-up visit
every 3 months