drugset / Trial / NCT00346801
CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)
Phase 1
Completed
20 enrolled
M.D. Anderson Cancer Center
National Comprehensive Cancer Network · collab
NaSingle-groupOpen-labelTreatment
Summary
Primary Objectives: * To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with unresectable NSCLC. * To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with irinotecan/cisplatin and concurrent thoracic radiation therapy. * To correlate the COX-2 expression and other biomarkers with response to the treatment in the tumor from a pretreatment biopsy specimen.
Timeline
- Start
- 2003-09
- Primary completion
- 2012-10
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celecoxib | Other / unclassified | 200 mg | Oral |
| Subject | Celecoxib | Other / unclassified | 400 mg | Oral |
| Subject | Celecoxib | Other / unclassified | 800 mg | Oral |
| Background | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Background | Irinotecan | Small molecule | 30 mg/m2 | Intravenous |