A Randomized Placebo-controlled Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients

INST 1420

There is a move towards personalized medicine in cancer care, and significant effort is underway to evaluate new targeted therapeutics for the treatment of ovarian cancer. One way to identify potential new drug targets is by screening a drug library to determine whether drugs in the library target key kinase or enzymatic sites in cellular signaling pathways. Previous preclinical work and pilot studies demonstrated that ketorolac (a type of non-steroidal anti-inflammatory drug) inhibits GTPase activity in ovarian cancer cells retrieved from the post-operative peritoneal cavity. The purpose of this study is to confirm that this inhibitory effect is ketorolac driven and not a specific effect of the post-operative peritoneal compartment.

2015-10-29

2018-10-08

2025-10-08

Active (not recruiting)

21

Inclusion Criteria: * 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 is allowable. * ECOG/Zubrod/SWOG Performance Status \<2 (Karnofsky Performance Status \> 70%) * Female' age ≥18 years * Ability to provide informed consent * Baseline laboratory values (bone marrow, renal, hepatic): * Adequate bone marrow function: * Absolute neutrophil count \>1000/µL * Platelet count \>100'000/µL * Renal function: * Serum creatinine \< 1.5 x ULN * Hepatic function: * Bilirubin \<1.5x 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 or allergy to NSAIDs * No active peptic ulcer disease * No active bleeding Secondary Eligibility * Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer confirmed on frozen section diagnosis during debulking surgery * Attempted maximal cytoreductive surgery. Patients will still be eligible whether optimal or suboptimally debulked at the completion of the surgery. * No active bleeding in the post-operative period Exclusion Criteria: * Non-epithelial ovarian cancer or metastatic cancer from another site to the ovaries * Borderline ovarian cancer without ascites * Uncontrolled or unstable medical conditions * Off study use of ketorolac or other NSAIDs prior to study administration within the perioperative window (7 days before surgery and up to the time of planned 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 1.5 mg/dL or creatinine clearance of \< 40 ml/min * Any co-morbid condition that' in the view of the attending physician' renders the patient at high risk from ketorolac treatment complications

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2024-01-11