drugset / Trial / NCT00211952
Adjuvant Celecoxib in Completely Resected pN1-2 NSCLC Patients
Phase 3
Suspended
542 enrolled
Medical University of Gdansk
Central and Eastern European Oncology Group · collabPharmacia · collabStowarzyszenie Ludzi Wyleczonych z Raka Płuca · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of the study is to assess the influence of celecoxib on relapse-free survival in completely resected patients with poor prognosis indicated by metastatic involvement of intrapulmonary/hilar (pN1) or ipsilateral mediastinal (pN2) lymph nodes. Celecoxib, a selective oral COX-2 inhibitor, was found to exert significant anti-proliferative activity against a variety of tumor cell lines in vitro, including NSCLC. COX-2 is frequently up-regulated in NSCLC cell lines and archival tumor samples. Its high expression was also correlated with poor prognosis of the patients. A clinical trial addressing the role of celecoxib as adjuvant treatment in radically operated patients with high risk of relapse is warranted.
Timeline
- Start
- 2004-03
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celecoxib | Other / unclassified | 400 mg | Oral |