NCT00385606

Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC

Phase II-III, Factorial Multicenter Randomized Trial Evaluating the Addition of Rofecoxib to Polycht With Cispatin and Gemcitabine and Fixed Dose Rate Infusion of Gem in Association With Cisplatin in 1st-line for Advanced NSCLC

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the tolerability and efficacy of the addition of rofecoxib to first-line chemotherapy, and to evaluate the efficacy of prolonged continuous infusion of gemcitabine in combination with cisplatin in the treatment of patients affected by advanced non-small cell lung cancer.

Detailed description

The primary end-points of the GECO study * To evaluate the tolerability of three innovative schedules of treatment for advanced NSCLC * To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy in the treatment of patients affected by advanced NSCLC * To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine, with the fixed infusion rate of 10 mg/sqm/minute) versus the standard administration in 30 minutes, in combination with cisplatin, in the treatment of patients affected by advanced NSCLC Four treatment arms are planned. * ARM A standard treatment : cisplatin + gemcitabine * ARM B cisplatin + gemcitabine + rofecoxib * ARM C cisplatin + p.c.i. gemcitabine (10 mg/sqm/minute) * ARM D cisplatin + p.c.i gemcitabine (10 mg/sqm/minute) + rofecoxib The phase II part of the study for experimental arms B, C and D will be conducted to evaluate tolerability in the three treatment arms. The phase III study for efficacy has been designed according to a factorial 2x2 model with the planned comparison of * The efficacy of rofecoxib: A + C (arms without rofecoxib) vs B+D (arms with rofecoxib) * The efficacy of p.c.i. gemcitabine: A + B (arms with standard infusion of gemcitabine) vs C+ D (arms with p.c.i gemcitabine)

Conditions

• Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine
DRUG	prolonged continuous infusion gemcitabine
DRUG	cisplatin
DRUG	rofecoxib

Timeline

• Start date: 2003-01-01
• Primary completion: 2005-12-01
• Completion: 2006-07-01
• First posted: 2006-10-11
• Last updated: 2023-03-23

Locations

25 sites across 1 country: Italy