Clinical trial · Interventional
Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients
A Randomized Placebo-controlled Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketorolac | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ketorolac
- description
- Once deemed stable in the first 1-3 post-operative days, patients will be receive age-based ketorolac (30 mg \<65, 15mg \> 65) daily for three days
- interventionNames
- Drug: Ketorolac
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Once deemed stable in the first 1-3 post-operative days, patients will be receive placebo daily for three days
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Ketorolac inhibition of GTPase activity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 complicationsReferences
Publications (0)
Data not yet available