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Ketorolac for Ovarian Cancer

N/A
Waitlist Available
Led By Carolyn Y. Muller, MD
Research Sponsored by New Mexico Cancer Research Alliance
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be suspected of having a diagnosis of ovarian, fallopian tube or primary peritoneal cancer with a planned cytoreductive surgery
Adequate bone marrow function: Absolute neutrophil count >1000/µL, Platelet count >100'000/µL
Must not have
Non-epithelial ovarian cancer or metastatic cancer from another site to the ovaries
Uncontrolled or unstable medical conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years following first ketorolac treatment
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing whether ketorolac can help treat ovarian cancer by looking at how it affects cancer cells in the body.

Who is the study for?
This trial is for women over 18 with suspected or confirmed ovarian, fallopian tube, or primary peritoneal cancer who are undergoing surgery. They must be in good health otherwise, with no active bleeding, known bleeding disorders, peptic ulcers, allergies to NSAIDs like ibuprofen, and not taking other NSAIDs or anticoagulants around the time of surgery.
What is being tested?
The study tests if Ketorolac (a painkiller) can inhibit certain cellular activities linked to ovarian cancer growth when given after surgery. Patients will either receive Ketorolac or a placebo to see if there's a difference between the two groups.
What are the potential side effects?
Ketorolac may cause side effects such as stomach pain and ulcers, heartburn, nausea, vomiting; it can also increase the risk of bleeding. It might affect kidney function and could lead to allergic reactions in those sensitive to NSAIDs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am suspected to have ovarian, fallopian tube, or peritoneal cancer and am planning to undergo surgery to remove it.
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My blood tests show enough neutrophils and platelets.
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I do not have any known bleeding disorders.
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My liver tests are within the required range.
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I do not have an active stomach ulcer.
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I am not currently experiencing any bleeding.
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My cancer diagnosis was confirmed during surgery.
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I am a woman aged 18 or older.
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I am mostly self-sufficient and can carry out daily activities.
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I am not experiencing any bleeding after surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer is not ovarian but has spread to the ovaries.
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My health conditions are stable and under control.
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I am currently on medication to prevent blood clots.
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My kidney function is impaired with high creatinine or low clearance.
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I am currently experiencing active bleeding or am at high risk for bleeding.
Select...
My ovarian cancer is borderline without fluid buildup in my abdomen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years following first ketorolac treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years following first ketorolac treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ketorolac inhibition of GTPase activity
Secondary study objectives
Intraperitoneal and serum pharmacokinetics of ketorolac
Time to CA-125 normalization
Toxicity assessment
Other study objectives
Overall survival (Exploratory objective)
Progression free survival (Exploratory objective)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: KetorolacExperimental Treatment1 Intervention
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
Group II: PlaceboPlacebo Group1 Intervention
Once deemed stable in the first 1-3 post-operative days, patients will be receive placebo daily for three days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac
FDA approved

Find a Location

Who is running the clinical trial?

New Mexico Cancer Research AllianceLead Sponsor
70 Previous Clinical Trials
52,438 Total Patients Enrolled
New Mexico Cancer Care AllianceLead Sponsor
70 Previous Clinical Trials
52,438 Total Patients Enrolled
Carolyn Y. Muller, MDPrincipal InvestigatorUniversity of New Mexico Comprehensive Cancer Center
1 Previous Clinical Trials

Media Library

Ketorolac Clinical Trial Eligibility Overview. Trial Name: NCT02470299 — N/A
Peritoneal Neoplasm Research Study Groups: Ketorolac, Placebo
Peritoneal Neoplasm Clinical Trial 2023: Ketorolac Highlights & Side Effects. Trial Name: NCT02470299 — N/A
Ketorolac 2023 Treatment Timeline for Medical Study. Trial Name: NCT02470299 — N/A
~2 spots leftby Dec 2025
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