title: Docetaxel and exisulind in previously treated non-small cell lung cancer (NSCLC) patients: a multicenter, phase II clinical trial.
abstract: OBJECTIVE
  This multicenter, phase II clinical trial was conducted to evaluate the activity of the combination of docetaxel and exisulind in advanced non-small cell lung cancer (NSCLC) patients who failed a prior platinum-containing regimen.
  
  
  METHODS
  Patients with measurable disease and adequate organ function received exisulind (250 mg) given orally, twice daily, and docetaxel (36 mg/m) administered intravenously on days 1, 8, and 15 of a 4-week cycle for up to six cycles. In the absence of disease progression or intolerable side effects, patients continued taking 250 mg of exisulind orally, twice daily.
  
  
  RESULTS
  Thirty-three patients (median age 60 years; range 34-77; median performance status 1) were enrolled. There were no objective responses documented. Sixteen patients [48%, 95% confidence interval (CI): 31%-66%] had stable disease after 8 weeks of treatment. Median progression-free survival (PFS) was 2.1 months (95% CI: 1.5-3.2 months); median overall survival time was 8.0 months (range 0.2-25.9 months). Toxicity was moderate, with dose adjustment for adverse event/toxicity required for docetaxel or exisulind in 13 (39.3%) patients. Grade 3/4 lymphopenia, neutropenia, and anemia occurred in 48.5%, 12.1%, and 9.1% of patients, respectively. Grade 3 or greater toxicity was seen in 12.1%, 6.1%, and 3% of patients for nausea/vomiting, dyspnea, and abdominal pain, respectively.
  
  
  CONCLUSIONS
  Treatment with exisulind and weekly docetaxel was not active in NSCLC patients who failed a prior platinum-containing regimen. Further study of this combination does not seem warranted.
authors.affiliation: TGen Clinical Research Services at Scottsdale Healthcare, Scottsdale, AZ, USA.
authors.forename: Glen J
authors.initials: GJ
authors.lastname: Weiss
authors.forename: Everett E
authors.initials: EE
authors.lastname: Vokes
authors.forename: Paul A
authors.initials: PA
authors.lastname: Bunn
authors.forename: Lyn
authors.initials: L
authors.lastname: Magree
authors.forename: Jason
authors.initials: J
authors.lastname: Rusk
authors.forename: Don
authors.initials: D
authors.lastname: Albert
authors.forename: Karen
authors.initials: K
authors.lastname: Kelly
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D003131:Combined Modality Therapy; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011879:Radiotherapy Dosage; D012074:Remission Induction; D013467:Sulindac / Q000008:administration & dosage / Q000031:analogs & derivatives; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D013467:Sulindac; C025463:sulindac sulfone