Clinical Research Directory

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