Clinical trial · Interventional
Availability & Effect of Post-OP Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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
NCT01670799CI-TRIAL-00043667completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the anti-cancer effect of a pain medication called ketorolac (Toradol) on ovarian cancer cells in the abdominal (peritoneal) cavity after surgery for ovarian, fallopian tube or primary peritoneal cancer.
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 Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketorolac | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ketorolac
- description
- All patients will receive a single dose of IV ketorolac for pain management for the indication of post-operative pain control. Patients less than 65 years of age and in otherwise good health will receive a 30mg IV single dose. Patients 65 years of age or greater, or who have mild renal insufficiency or are of low weight (as per section 3.2) will receive a single 15 mg dose IV ketorolac. In patients who have a clinical pain response and have no contraindications to multi-dose (every 6 hours over 24 hours), additional doses will be given per physician discretion based on clinical indication. Patients receiving 24 hour dosing will be eligible for sample time points after 24 hour dosing.
- interventionNames
- Drug: Ketorolac
Primary outcomes (1)
- measure
- Measure levels of Ketorolac in peritoneal cavity
- timeFrame
- 24 hours
- description
- To determine the concentration of measurable levels of R and S- Ketorolac (and the percent racemic mixture) in the peritoneal cavity after intravenous (IV) administration in the post-operative patient after cytoreductive surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.