NCT02470299Completed
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 · Last updated 22 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 10 Jun 2015
- Start date
- 29 Oct 2015
- Primary completion date
- 8 Oct 2018
- Lead sponsor
- New Mexico Cancer Research Alliance
- Diseases
- Ovarian cancer
- NCT number
- NCT02470299
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 29 Oct 2015 to the primary completion date, 8 Oct 2018
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Non-epithelial ovarian cancer or metastatic cancer from another site to the ovaries
- Borderline ovarian cancer without ascites
- Uncontrolled or unstable medical conditions
- Active bleeding or high risk of bleeding
- Known hypersensitivity to NSAIDs
- Any co-morbid condition that' in the view of the attending physician' renders the patient at high risk from ketorolac treatment complications
Lab values
- 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
Other
- Active therapeutic anticoagulation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universtiy of New Mexico Comprehensive Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.