Trial intelligence / Profile preview

Celecoxib + Docetaxel in Elderly/Poor PS Advanced NSCLC

NCT00030407Phase 2

Key facts

Status: Completed
Start: Oct 2001
Primary completion: Sep 2005
Countries: 1
Sponsor: Barbara Ann Karmanos Cancer Institute
Modality: Small Molecules

Drugs: celecoxib oral solution
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, open-label, single-arm trial of celecoxib oral solution in non-small cell lung cancer (NSCLC), sponsored by Barbara Ann Karmanos Cancer Institute. Primary endpoint: Efficacy of combining celecoxib with docetaxel. Started Oct 2001; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Celecoxib & Docetaxel
Celecoxib lead-in followed by Celecoxib + Docetaxel combination cycles.

Who it enrols

Patients with Stage IIIB/IV NSCLC, aged >=70 with PS 0-2 OR aged 18-69 with PS 2. No prior chemotherapy or biologic therapy for NSCLC.

Endpoints

Primary

Efficacy of combining celecoxib with docetaxelWeeks 1, 2, and 3

Secondary

Response rate of Celecoxib and DocetaxelEvery 2 cycles (or every 42 days)
Toxicity of Celecoxib and DocetaxelWeeks 1, 2, and 3 of each 28 day cycle
Expression of cyclooxygenase-2 (COX-2) in tumorsPre-Study
Changes in plasma levels of prostaglandin E2(PGE2) & vascular endothelial growth factor (VEGF)Weeks 1, 2 and 5

Beyond the preview

Go deeper on NCT00030407.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00030407.