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Common painkiller may boost Chemo's power against cancer

NCT ID NCT01719926

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested whether adding indomethacin, a common anti-inflammatory drug, to standard platinum-based chemotherapy is safe for people with colorectal, esophageal, or ovarian cancers. The 13 participants received escalating doses of indomethacin alongside their chemo. The main goal was to find safe dosing levels and watch for side effects, not to measure effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Indomethacin (a COX inhibitor, similar to ibuprofen) combined with platinum-based chemotherapy
What this could lead to
If successful, this could point toward a way to make chemotherapy more effective by blocking resistance signals from stem cells.
What could go wrong
This is a very early, small Phase 1 trial with only 13 participants. It only tests safety and dosing, not whether it actually works. Indomethacin can cause stomach bleeding or kidney issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Start date

Sep 2012

Finished

Aug 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects with a histological proven malignancy receiving cisplatin combined with gemcitabine or 5FU/capecitabine. (cisplatin dose range 60-80 mg/m2) (Arm I) or CAPOX (oxaliplatin, capecitabine) (Arm II) in a 21 day cycle. * Age ≥ 18 years * Platinum-based chemotherapy naïve for at least 6 months. * Subjects with at least one evaluable lesion. * WHO Performance Status of 0 or 1. * Female participants should be of non-child bearing potential either physiologic or by using adequate contraception, have a negative serum pregnancy test, and refrain from breast feeding. * Written informed consent. Exclusion Criteria: * Known or suspected allergy or hypersensitivity to indomethacin or any agent given in association with this trial, in particular subjects who have a history of severe hypersensitivity reactions to anti-emetics (5-HT3 antagonists, metoclopramide or corticosteroids) and acetylsalicylic acid or other prostaglandin synthetase inhibitors. * Symptomatic brain or meningeal tumors * Subjects with seizure disorder requiring medication (such as corticosteroids or anti-epileptics). * Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: * Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen * Unstable angina pectoris * Symptomatic congestive heart failure NYHA class ≥ 3 (see appendix 13.6) * Myocardial infarction ≤ 6 months prior to randomization * Serious uncontrolled cardiac arrhythmia * Active peptic ulcer disease, gastritis, inflammatory bowel disease. * History of active gastrointestinal bleeding * History of cerebrovascular disease * Bleeding diathesis * Chronic renal disease defined as GFR (MDRD) \<60 ml/min * Absolute Neutrophil Count (ANC) \< 1.5 x 109/L (\< 1500/mm3) * Platelets (PLT) \< 100 x 109/L (\< 100,000/mm3) * Hemoglobin (Hgb) \< 6.0 mmol/l (patients may be transfused to achieve adequate Hb) * Partial thromboplastin time (PTT) \> 1,5 x ULN * Serum bilirubin \> 1.5 ULN * Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \> 3.0 x ULN (\> 5 x ULN if liver metastases present) * Patients who are unable or unwilling to comply with the protocol * Chronic treatment with a corticosteroid agent (nebulized corticosteroids are allowed) * Patients who received radiation therapy within 4 weeks of the start of the study * Patients who received an experimental agent less than 4 weeks before start of the study. * Patients who used Omega-3/omega-6 containing products, including fish oil products less than 2 weeks before start of the study. * Chronic use of NSAID's and/or acetylsalicylic acid and/or other prostaglandin synthetase inhibitors. * Use of anticoagulant therapy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Meander Medisch Centrum

    Amersfoort, Utrecht, 3813TZ, Netherlands

  • Oncology Institute of Southern Switzerland

    Bellinzona, CH-6500, Switzerland

  • UMC Utrecht

    Utrecht, Utrecht, 3584CX, Netherlands

  • the Netherlands Cancer Institute

    Amsterdam, Amsterdam, 1066 CX, Netherlands

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