title: Phase II study of docetaxel and celecoxib, a cyclooxygenase-2 inhibitor, in elderly or poor performance status (PS2) patients with advanced non-small cell lung cancer.
abstract: BACKGROUND
  The utility of two-drug chemotherapy regimens in elderly or performance status (PS 2) patients with advanced non-small cell lung cancer (NSCLC) remains to be established. Preclinical studies suggested that celecoxib, a Cyclooxygenase-2 inhibitor, has antitumor activity in NSCLC and can enhance the activity of chemotherapy drugs. We conducted a phase II study to evaluate the efficacy of the combination of weekly docetaxel and celecoxib in advanced NSCLC patients, who were either elderly (> or =70 years) or PS2.
  
  
  METHODS
  Patients with stage IIIB (with pleural effusion) or IV NSCLC who were > or =70 years and had a PS of 0-2 or patients of any age with a PS of 2 were included. Patients should have been off any nonsteroidal anti-inflammatory drug for 30 continuous days before study enrollment. Patients were treated with weekly docetaxel 36 mg/m i.v. on days 1, 8, 15 of a 28 day cycle and Celecoxib 400 mg po twice daily. Disease assessment was performed after every two cycles. The study design required 39 patients.
  
  
  RESULTS
  Study was terminated after 34 patients were enrolled due to safety concerns regarding celecoxib. Thirty patients were evaluable. The response rate was 15%. The median progression free survival and median survival were 2.3 months and 5.0 months, respectively. The median survival of patients > or =70 years old with a PS of 0-1 was 8.3 months and the median survival of PS2 patients was 2.8 months. The combination was well tolerated with fatigue as the most common adverse effect. Two patients developed arterial thrombotic events.
  
  
  CONCLUSIONS
  In these 'special populations' of patients with advanced NSCLC, the addition of celecoxib to docetaxel did not seem to improve the outcome compared with single agent docetaxel.
authors.affiliation: Thoracic Oncology Program, Karmanos Cancer Institute/Wayne State University, Detroit, Michigan, USA. gadgeels@karmanos.org
authors.forename: Shirish M
authors.initials: SM
authors.lastname: Gadgeel
authors.forename: Antoinette
authors.initials: A
authors.lastname: Wozniak
authors.forename: John C
authors.initials: JC
authors.lastname: Ruckdeschel
authors.forename: Lance K
authors.initials: LK
authors.lastname: Heilbrun
authors.forename: Raghu
authors.initials: R
authors.lastname: Venkatramanamoorthy
authors.forename: Ruth A
authors.initials: RA
authors.lastname: Chaplen
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Kraut
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Kalemkerian
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D000068579:Celecoxib; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011720:Pyrazoles / Q000008:administration & dosage; D013449:Sulfonamides / Q000008:administration & dosage; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D043823:Taxoids; D000077143:Docetaxel; D000068579:Celecoxib