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
1 other identifier
interventional
400
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2003
Typical duration for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 10, 2006
CompletedFirst Posted
Study publicly available on registry
October 11, 2006
CompletedMarch 23, 2023
April 1, 2015
2.9 years
October 10, 2006
March 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To evaluate the tolerability of three experimental treatment schedules
adverse events according to CTCAE criteria
at the end of each cycle of chemotherapy (every 3 weeks) until 21 days after the last treatment administrationministration
To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy
response rate according to RECIST criteria
at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year).
To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine vs standard infusion, in combination with cisplatin
response rate according to RECIST criteria
at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year).
Study Arms (4)
cisplatino plus gemcitabine
ACTIVE COMPARATORGemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.
cisplatino plus gemcitabine plus rofecoxib
EXPERIMENTALGemcitabina 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.
cisplatino plus gemcitabine 10 mg/m2/min
EXPERIMENTALGemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.
cisplatino plus gemcitabine 10 mg/m2/min plus rofecoxib
EXPERIMENTALGemcitabina 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.
Interventions
Eligibility Criteria
You may qualify if:
- Cytologic or histologic diagnosis of non-small cell lung cancer
- Disease stage IIIB or IV
- Age less than 70 years
- ECOG performance status 2 or less
- Patients with cerebral metastases are permitted if they are asymptomatic and do not require radiation therapy concomitant with chemotherapy
- Negative history of allergy to non-steroidal anti-inflammatory and/or sulphonamide drugs
- Patients previously treated with radiation therapy are permitted if at least 4 weeks have passed since last therapy
- Written informed consent
You may not qualify if:
- Previous chemotherapy
- Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
- Neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 10 g/dl
- Creatinine \> 1.25 x the upper normal limits
- GOT and/or GPT and/or Bilirubin \> 1.25 the upper normal limits in absence of hepatic metastases
- GOT and/or GPT and/or Bilirubin \> 2.5 the upper normal limits in presence of hepatic metastases
- Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
- Inability to comply with follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, 83024, Italy
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, 70021, Italy
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, 70126, Italy
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
Bari, BA, 70126, Italy
Policlinico Universitario, Oncologia Medica II
Cagliari, CA, 09042, Italy
Ospedale A. Cardarelli
Campobasso, CB, 86100, Italy
Ospedale Mariano Santo, U.O. di Oncologia Medica
Cosenza, CS, 87100, Italy
Ospedale Umberto di Frosinone
Frosinone, FR, 03031, Italy
Ospedale Civile di Legnano
Legnano, MI, Italy
Ospedale S. Paolo
Milan, MI, 20142, Italy
Policlinico Universitario P. Giaccone
Palermo, PA, 90100, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
Palermo, PA, 90146, Italy
Istituto Oncologico Veneto
Padua, PD, Italy
Ospedale Civile Umberto I, Day Hospital Oncoematologico
Nocera Inferiore, SA, 84014, Italy
Divisione di Oncologia Medica, U.S.L.L. 13
Noale, VE, 30033, Italy
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, 36100, Italy
Ospedale L. Sacco
Milan, Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, 80131, Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, 80131, Italy
Second University of Naples
Napoli, Italy
Ospedale Santa Corona
Pietre Ligure, Italy
Istituto Regina Elena, Divisione di Oncologia Medica
Roma, 00144, Italy
Ospedale S. Giovanni Calibita Gatebenefratelli
Roma, 00186, Italy
Ospedale San Camillo - Forlanini
Rome, Italy
Azienda Ospedaliera Di Busto Arsizio
Saronno, Italy
Related Publications (2)
Gridelli C, Gallo C, Ceribelli A, Gebbia V, Gamucci T, Ciardiello F, Carozza F, Favaretto A, Daniele B, Galetta D, Barbera S, Rosetti F, Rossi A, Maione P, Cognetti F, Testa A, Di Maio M, Morabito A, Perrone F; GECO investigators. Factorial phase III randomised trial of rofecoxib and prolonged constant infusion of gemcitabine in advanced non-small-cell lung cancer: the GEmcitabine-COxib in NSCLC (GECO) study. Lancet Oncol. 2007 Jun;8(6):500-12. doi: 10.1016/S1470-2045(07)70146-8.
PMID: 17513173RESULTDi Maio M, Gallo C, Leighl NB, Piccirillo MC, Daniele G, Nuzzo F, Gridelli C, Gebbia V, Ciardiello F, De Placido S, Ceribelli A, Favaretto AG, de Matteis A, Feld R, Butts C, Bryce J, Signoriello S, Morabito A, Rocco G, Perrone F. Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol. 2015 Mar 10;33(8):910-5. doi: 10.1200/JCO.2014.57.9334. Epub 2015 Jan 26.
PMID: 25624439DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cesare Gridelli, M.D.
San Giuseppe Moscati Hospital, Avellino, Italy
- PRINCIPAL INVESTIGATOR
Francesco Perrone, M.D., Ph.D.
National Cancer Institute Naples, Italy
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2006
First Posted
October 11, 2006
Study Start
January 1, 2003
Primary Completion
December 1, 2005
Study Completion
July 1, 2006
Last Updated
March 23, 2023
Record last verified: 2015-04