Common painkiller may boost Chemo's power against cancer
NCT ID NCT01719926
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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13 people
The number who actually took part.
- Start date
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Sep 2012
- Finished
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Aug 2017
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Meander Medisch Centrum
Amersfoort, Utrecht, 3813TZ, Netherlands
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Oncology Institute of Southern Switzerland
Bellinzona, CH-6500, Switzerland
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UMC Utrecht
Utrecht, Utrecht, 3584CX, Netherlands
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the Netherlands Cancer Institute
Amsterdam, Amsterdam, 1066 CX, Netherlands
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