Effect of Celecoxib on Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Chemotherapy

• Status: Unknown status
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the study is to investigate if daily treatment with celecoxib, an inhibitor of cyclooxygenase-2, can prolong survival in patients with advanced non-small cell lung cancer who receive anticancer chemotherapy as their primary treatment. Secondary endpoints of the study are: health-related quality of life, toxicity, cardiovascular events, progression-free survival, and biological markers (VEGF, proteomics).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Linkoeping
• Collaborators: Pfizer; Swedish Lung Cancer Study Group
• Treatments: Celecoxib

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