Cancer malignancy
Conditions
Interventions
All patients will receive their first chemotherapy cycle according standard of
care without addition of indomethacin. If no toxicity as defined in table 3.1.1
is observed Indomethacin will be admini
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Subjects with a histological proven malignancy receiving cisplatinum combined with gemcitabine or 5FU/capecitabin (dose range cisplatin 60-80 mg/m2) (Arm I) or CAPOX (oxaliplatin, capecitabine) (Arm II) in a 21 day cycle. - Platinum*based chemotherapy naïve for at least 6 months. - Age * 18 years. - 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
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 synthethase inhibitors. - Symptomatic brain or meningeal tumors - Subjects with seizure disorder requiring medication (such as steroids 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 gastro-intestinal bleeding - History of cerebro-vascular disease - Bleeding diathesis - Chronic renal disease defined as GFR (MDRD) 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 synthethase inhibitors. - Use of anticoagulant therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: Safety of the combination of platinum-based therapy and indomethacin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Pharmacodynamics of the combination of platinum-based chemotherapy and indomethacin. Efficacy. Tolerability. | — |
Countries
Netherlands
Outcome results
None listed