What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, particularly those involving COX enzyme inhibition such as ketorolac and celecoxib, often result in side effects like gastrointestinal issues (nausea, vomiting, diarrhea), cardiovascular risks, and renal impairment. Chemotherapeutic agents like gemcitabine and cisplatin can cause myelosuppression, neuropathy, and alopecia. These side effects can significantly impact the patient's quality of life and may require dose adjustments or additional supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including gemcitabine-based therapies and combination regimens. Notably, cyclooxygenase-2 (COX-2) inhibitors like celecoxib have been studied in combination with chemotherapy agents such as gemcitabine and cisplatin. These combinations aim to improve survival rates and manage symptoms in patients with advanced pancreatic cancer. While ketorolac, another COX inhibitor, is being studied for its potential benefits in stabilizing weight and improving quality of life, it has not yet received FDA approval specifically for pancreatic cancer treatment.

What other types of research exist?

Promising alternatives to Ketorolac for pancreatic cancer treatment include the combined use of COX-2 inhibitors like celecoxib with 5-LOX inhibitors (e.g., MK886) and novel agents targeting KRAS mutations, such as sotorasib.

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Nonsteroidal Anti-inflammatory Drug

Ketorolac for Cachexia in Pancreatic Cancer (KetoROCX Trial)

Phase < 1

Waitlist Available

Research Sponsored by Andrew Hendifar, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky performance status >50%

Diagnosis of advanced and refractory pancreatic ductal adenocarcinoma (PDAC) referred to Cedars-Sinai Medical Center (CSMC)

Must not have

Concurrent use of any other NSAIDs while on study

Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if ketorolac, a drug that reduces pain and swelling, can help pancreatic cancer patients maintain or gain weight and feel better overall. Ketorolac has been used effectively for pain management in various surgical procedures, including in children and infants.

Who is the study for?

This trial is for adults with advanced pancreatic cancer and cachexia, which means they've lost a lot of weight due to illness. They need good kidney function, internet access for a Smart Scale, and an ECOG performance status ≤2 or Karnofsky >50%. Pregnant women or those at risk of bleeding can't join.

What is being tested?

The study tests if ketorolac, an anti-inflammatory drug, is safe and effective in stabilizing or increasing the weight and improving quality of life in patients with advanced pancreatic cancer who are experiencing significant weight loss.

What are the potential side effects?

Ketorolac may cause side effects like stomach ulcers, gastrointestinal bleeding, kidney problems, allergic reactions, and increased risk of bleeding. It's important to monitor these potential issues throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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I have advanced pancreatic cancer that has not responded to treatment and am referred to Cedars-Sinai.

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My kidney function, measured by creatinine levels or filtration rate, is within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any other NSAIDs while participating in this study.

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I have a history of stomach ulcers or recent stomach bleeding.

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I am not allergic to the study drug, surgical steel, or rubber.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days.

Secondary study objectives

Decrease in inflammatory biomarkers (CA-19 and CRP) from baseline

Evaluate change in physical function from baseline through the End-of Study visit

Evaluate change in quality of life including pain assessment from baseline through the End-of-Study visit

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketorolac (open label)Experimental Treatment1 Intervention

Pancreatic patients receiving Ketorolac four times a day for up to five days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketorolac Tromethamine

2007

Completed Phase 4

~1450

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer often target specific molecular pathways to inhibit tumor growth and progression. One such mechanism involves the inhibition of cyclooxygenase (COX) enzymes, particularly COX-2, which is overexpressed in many pancreatic cancers and contributes to tumor growth and resistance to therapy. Drugs like Ketorolac and celecoxib are COX inhibitors that aim to reduce inflammation and tumor proliferation. Additionally, gemcitabine, a nucleoside analog, interferes with DNA replication, leading to cell death. Combination therapies, such as gemcitabine with COX-2 inhibitors, have shown promise in enhancing treatment efficacy. These mechanisms are crucial as they offer targeted approaches to manage this aggressive cancer, potentially improving patient outcomes and quality of life.

Novel therapeutic targets for pancreatic cancer.A triple combination of atorvastatin, celecoxib and tipifarnib strongly inhibits pancreatic cancer cells and xenograft pancreatic tumors.COX-2 and NF-KB overexpression is common in pancreatic cancer but does not predict for COX-2 inhibitors activity in combination with gemcitabine and oxaliplatin.