Phase II study of celecoxib and docetaxel in non-small cell lung cancer (NSCLC) patients with progression after platinum-based therapy.
BACKGROUND
To evaluate the efficacy and toxicity of the combination of celecoxib and docetaxel in patients with advanced non-small cell lung cancer after failure of platinum-based therapy.


METHODS
Patients with relapsed non-small cell lung cancer received celecoxib 400 mg orally twice daily beginning 7 days before the first cycle of docetaxel and the celecoxib was continued with no interruption. Docetaxel 75 mg/m2 was administered intravenously on a 21-day cycle. The primary end point of the study was the 6-month survival rate.


RESULTS
Twenty-four patients were enrolled and twenty patients were treated (median age 60, M:F 16:8). Most patients had a baseline performance status of 1. The objective response rate was 10% (95% confidence interval [CI], 0-25%) and the 6-month survival rate was 59% (95% CI 37-80%). Median survival time was 6.9 months (95% CI, 2.8-15.2 months) and the 1- and 2-year survival rates were 36% (95% CI, 15-57%) and 1% (95% CI, 0-10%), respectively. The most frequent grade > or =3 adverse events were neutropenia (58%) and neutropenic fever (21%) which resulted in early closure of the trial.


CONCLUSIONS
The addition of celecoxib to docetaxel did not seem to improve the response rate and survival compared with docetaxel alone. The combination demonstrated considerable neutropenia and complications from febrile neutropenia that suggests celecoxib may enhance the marrow toxicity of docetaxel.
Schneider
Bryan J
BJ
Department of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, Michigan, USA. bryansch@umich.edu
Kalemkerian
Gregory P
GP
Kraut
Michael J
MJ
Wozniak
Antoinette J
AJ
Worden
Francis P
FP
Smith
Daryn W
DW
Chen
Wei
W
Gadgeel
Shirish M
SM
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D000068579:Celecoxib; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000188:drug therapy; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000009:adverse effects*; D011720:Pyrazoles / Q000008:administration & dosage; D016879:Salvage Therapy; D013449:Sulfonamides / Q000008:administration & dosage; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; D011720:Pyrazoles; D013449:Sulfonamides; D043823:Taxoids; D000077143:Docetaxel; D000068579:Celecoxib