Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Gemcitabine

Cisplatin

Cyclooxygenase 2 Inhibitors

Rofecoxib

Antimetabolites

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.

Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.

Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.

Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.

gemcitabine

prolonged continuous infusion gemcitabine

cisplatin

rofecoxib

Cesare Gridelli, M.D.

Francesco Perrone, M.D., Ph.D.

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.

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)

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

adverse events according to CTCAE criteria

response rate according to RECIST criteria

National Cancer Institute, Naples

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC	NCT00385606	Advanced Non-sm...	gemcitabine prolonged conti... cisplatin rofecoxib	18 Years - 70 Years	National Cancer Institute, Naples
Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC	NCT00385606	Advanced Non-sm...	gemcitabine prolonged conti... cisplatin rofecoxib	18 Years - 70 Years	National Cancer Institute, Naples

Spots Global Cancer Trial Database for prolonged continuous infusion