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GECO: Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00385606
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : August 23, 2007
Information provided by:
National Cancer Institute, Naples

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.

Condition or disease Intervention/treatment Phase
Advanced Non-Small Cell Lung Cancer Drug: gemcitabine Drug: prolonged continuous infusion gemcitabine Drug: cisplatin Drug: rofecoxib Phase 2 Phase 3

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)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. To evaluate the tolerability of three experimental treatment schedules
  2. To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy
  3. To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine vs standard infusion, in combination with cisplatin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385606

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy, 83024
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, Italy, 70021
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
Bari, BA, Italy, 70126
Policlinico Universitario, Oncologia Medica II
Cagliari, CA, Italy, 09042
Ospedale A. Cardarelli
Campobasso, CB, Italy, 86100
Ospedale Mariano Santo, U.O. di Oncologia Medica
Cosenza, CS, Italy, 87100
Ospedale Umberto di Frosinone
Frosinone, FR, Italy, 03031
Ospedale Civile di Legnano
Legnano, MI, Italy
Ospedale S. Paolo
Milano, MI, Italy, 20142
Policlinico Universitario P. Giaccone
Palermo, PA, Italy, 90100
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
Palermo, PA, Italy, 90146
Istituto Oncologico Veneto
Padova, PD, Italy
Ospedale Civile Umberto I, Day Hospital Oncoematologico
Nocera Inferiore, SA, Italy, 84014
Divisione di Oncologia Medica, U.S.L.L. 13
.Noale, VE, Italy, 30033
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, Italy, 36100
Ospedale L. Sacco
Milano, Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, Italy, 80131
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, Italy, 80131
Second University of Naples
Napoli, Italy
Ospedale Santa Corona
Pietre Ligure, Italy
Istituto Regina Elena, Divisione di Oncologia Medica
Roma, Italy, 00144
Ospedale S. Giovanni Calibita Gatebenefratelli
Roma, Italy, 00186
Ospedale San Camillo - Forlanini
Rome, Italy
Azienda Ospedaliera Di Busto Arsizio
Saronno, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00385606     History of Changes
Other Study ID Numbers: GECO
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: August 23, 2007
Last Verified: August 2007

Keywords provided by National Cancer Institute, Naples:
prolonged continuous infusion
Cox-2 inhibitors

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents