A Pilot Trial to Study the Availability and Effect of Post-OP IV Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer, Cells Retrieved From the Peritoneal Cavity

Fecha de inicio: 1 de marzo de 2012

Inclusion Criteria: (PRE-OPERATIVE [OP]) Patients must be suspected of having a diagnosis of ovarian, fallopian tube or primary peritoneal cancer with a planned cytoreductive surgery Borderline ovarian cancer with ascites Eastern Cooperative Oncology Group (ECOG)/Zubrod/ Southwest Oncology Group (SWOG) performance status < 2 (Karnofsky performance status >= 70%) Ability to provide informed consent Absolute neutrophil count > 1000/uL Platelet count > 100'000/uL Serum creatinine =< 1.5 x upper limit of normal (ULN) Bilirubin =< 1.5 x normal Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels =< 2 x ULN No known bleeding disorders No known sensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) No active peptic ulcer disease No active bleeding SECONDARY ELIGIBILITY Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer on frozen section diagnosis Placement of an intraperitoneal port at the time of surgery for anticipated use for adjuvant chemotherapy or management of post-operative ascites If epidural catheter was used - the catheter must be removed prior to treatment No active bleeding Exclusion Criteria: Non-epithelial ovarian cancer or metastatic cancer to the ovaries Borderline ovarian cancer without ascites Presumed early stage ovarian cancer No clinical indication for a peritoneal port Active use of an epidural catheter Uncontrolled or unstable medical conditions Off study use of ketorolac or other NSAIDs prior to study administration Active bleeding or high risk of bleeding Active therapeutic anticoagulation Known hypersensitivity to NSAIDs Chronic or acute renal insufficiency as defined by a preoperative serum creatinine greater than 1.5mg/dL or creatinine clearance of < 60 ml/min Any co-morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications