Spots Global Cancer Trial Database for Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC
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Trial Identification
Brief Title: Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC
Official Title: 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
Study ID: NCT00385606
Conditions
Study Description
Brief 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)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica, Monteforte Irpino, AV, Italy
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica, Acquaviva delle Fonti, BA, Italy
IRCCS Oncologico Bari, Oncologia Medica, Bari, BA, Italy
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale, Bari, BA, Italy
Policlinico Universitario, Oncologia Medica II, Cagliari, CA, Italy
Ospedale A. Cardarelli, Campobasso, CB, Italy
Ospedale Mariano Santo, U.O. di Oncologia Medica, Cosenza, CS, Italy
Ospedale Umberto di Frosinone, Frosinone, FR, Italy
Ospedale Civile di Legnano, Legnano, MI, Italy
Ospedale S. Paolo, Milano, MI, Italy
Policlinico Universitario P. Giaccone, Palermo, PA, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico, Palermo, PA, Italy
Istituto Oncologico Veneto, Padova, PD, Italy
Ospedale Civile Umberto I, Day Hospital Oncoematologico, Nocera Inferiore, SA, Italy
Divisione di Oncologia Medica, U.S.L.L. 13, Noale, VE, Italy
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica, Vicenza, VI, Italy
Ospedale L. Sacco, Milano, , Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Napoli, , Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C, Napoli, , Italy
Second University of Naples, Napoli, , Italy
Ospedale Santa Corona, Pietre Ligure, , Italy
Istituto Regina Elena, Divisione di Oncologia Medica, Roma, , Italy
Ospedale S. Giovanni Calibita Gatebenefratelli, Roma, , Italy
Ospedale San Camillo - Forlanini, Rome, , Italy
Azienda Ospedaliera Di Busto Arsizio, Saronno, , Italy
Contact Details
Name: Cesare Gridelli, M.D.
Affiliation: San Giuseppe Moscati Hospital, Avellino, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Perrone, M.D., Ph.D.
Affiliation: National Cancer Institute Naples, Italy
Role: PRINCIPAL_INVESTIGATOR
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