GECO: Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced Non-Small Cell Lung Cancer
Information source: National Cancer Institute, Naples
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Non-Small Cell Lung Cancer
Intervention: gemcitabine (Drug); prolonged continuous infusion gemcitabine (Drug); cisplatin (Drug); rofecoxib (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: National Cancer Institute, Naples Official(s) and/or principal investigator(s): Cesare Gridelli, M.D., Principal Investigator, Affiliation: San Giuseppe Moscati Hospital, Avellino, Italy Francesco Perrone, M.D., Ph.D., Principal Investigator, Affiliation: National Cancer Institute Naples, Italy
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.
Clinical Details
Official title: Phase II-III, Factorial Multicenter Randomized Trial Evaluating the Addition of Rofecoxib to Polychemotherapy With Cisplatin and Gemcitabine and the Fixed Dose Rate Infusion of Gemcitabine in Association With Cisplatin in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the tolerability of three experimental treatment schedulesTo evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine vs standard infusion, in combination with cisplatin
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.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Ospedale L. Sacco, Milano, 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
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, Milano, MI 20142, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico, Palermo, PA 90146, Italy
Policlinico Universitario P. Giaccone, Palermo, PA 90100, Italy
Istituto Oncologico Veneto, Padova, 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
Additional Information
Starting date: January 2003
Last updated: August 22, 2007
|