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Ketorolac for Ovarian Cancer

N/A

Waitlist Available

Led By Carolyn Y. Muller, MD

Research Sponsored by New Mexico Cancer Care 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

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.Check my eligibility

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.See study design

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:

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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.

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My ovarian cancer is borderline without fluid buildup in my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years following first ketorolac treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ketorolac inhibition of GTPase activity

Secondary outcome measures

Intraperitoneal and serum pharmacokinetics of ketorolac

Time to CA-125 normalization

Toxicity assessment

Other outcome measures

Overall survival (Exploratory objective)

Progression free survival (Exploratory objective)

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

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

New Mexico Cancer Care AllianceLead Sponsor

70 Previous Clinical Trials

52,446 Total Patients Enrolled

8 Trials studying Ovarian Cancer

254 Patients Enrolled for Ovarian Cancer

Carolyn Y. Muller, MDPrincipal InvestigatorUniversity of New Mexico Comprehensive Cancer Center

1 Previous Clinical Trials

1 Trials studying Ovarian Cancer

Media Library

Ketorolac Clinical Trial Eligibility Overview. Trial Name: NCT02470299 — N/A

Ovarian Cancer Research Study Groups: Ketorolac, Placebo

Ovarian Cancer 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 Jul 2025

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