Study of the Combination Carboplatin Plus Celecoxib in Heavily Pre-treated Recurrent Ovarian Cancer Patients
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the antitumor activity and potential adverse effects of
      the combination celecoxib plus carboplatin in patients with recurrent, heavily pre-treated
      Ovarian Cancer (OC). The potential changes induced by the experimental combination on
      angiogenesis-related serum markers and quality of life measures will be also evaluated.The
      main objective is to evaluate the response rate. Secondary objectives are the
      following:toxicity;progression free survival;overall survival;duration of response;quality of
      life;modulation of angiogenesis-related molecules.
    

Detailed description: 
      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
    

Intervention name(s): Carboplatin plus Celecoxib
Intervention type(s): Drug
Intervention description(s): 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).
Intervention MeSH terms: Celecoxib; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carboplatin plus Celecoxib; Pre-treated Recurrent Ovarian Cancer Patients; The antitumor activity and potential adverse effects; tumor response rate; toxicity; progression free survival; duration of response; quality of life