Effect of Celecoxib on Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Chemotherapy (CYCLUS)
Non-Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Cyclooxygenase-2 inhibitors, Celecoxib, Carcinoma, non-small-cell lung, Antineoplastic agents, Therapy, palliative, Survival
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Age at least 18 years. No upper age limit. Disease stage IIIB or IV. Performance status (WHO) 0-2 Treatment with curative intent is not possible No prior chemotherapy for the present disease Planned treatment is palliative chemotherapy WBC count at least 3.0, platelet count at least 100 Bilirubin < 1.5 * upper reference limit (URL), ASAT and ALAT < 3 * URL (<5 in case of liver metastases) Calculated creatinine clearance at least 40 mg/ml Informed oral and written consent Exclusion criteria: Regular use of NSAID (except ASA at a dose of 50-100 mg daily) Active duodenal ulcer, ongoing gastrointestinal bleeding or inflammatory bowel disease Serious heart failure or serious liver disease Hypersensitivity so sulfonamides Pregnancy Lactation
Sites / Locations
- Department of Pulmonary Medicine and Allergology, Sahlgrenska University Hospital
- Section of Pulmonary Medicine, Ryhov County Hospital
- Section of Pulmonary Medicine and Allergology, County Hospital of Kalmar
- Department of Pulmonary Medicine, University Hospital
- Department of Pulmonary Medicine and Allergy, Lund University Hospital
- Section of Pulmonary Medicine, Malmö University Hospital
- Department of Medicine, Skövde Hospital/KSS
- Department of Medicine, Trollhättan Hospital/NÄL
- Department of Medicine, Uddevalla Hospital
- Department of Pulmonary medicine, Umeå University Hospital
- Department of Pulmonary Medicine and Allergology, Uppsala University Hospital
- Department of Medicine, Ystad Hospital
- Department of Pulmonary Medicine, Örebro University Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Celecoxib
Placebo
Four cycles of combination chemotherapy, usually with carboplatin + gemcitabine or carboplatin + vinorelbine, plus celecoxib 400 mg b.i.d. Treatment with celecoxib is continued after completion of chemotherapy. Maximum treatment duration is one year.
Chemotherapy as in arm 1 plus placebo capsules, b.i.d.