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Advanced Non-small Cell Lung CancerPhase 2/3NCT00385606

Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC

A Phase 2/3 study testing gemcitabine, prolonged continuous infusion gemcitabine and cisplatin in people with Advanced Non-small Cell Lung Cancer, run by National Cancer Institute, Naples at 25 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Non-small Cell Lung Cancer
What is being tested?
gemcitabine, prolonged continuous infusion gemcitabine and cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
25 sitesItaly
Study dates
Jan 2003to Jul 2006
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Italy25 sites

  • Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica

    Acquaviva delle Fonti, BA, 70021

  • IRCCS Oncologico Bari, Oncologia Medica

    Bari, BA, 70126

  • Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale

    Bari, BA, 70126

  • Policlinico Universitario, Oncologia Medica II

    Cagliari, CA, 09042

  • Ospedale A. Cardarelli

    Campobasso, CB, 86100

  • Ospedale Mariano Santo, U.O. di Oncologia Medica

    Cosenza, CS, 87100

  • Ospedale Umberto di Frosinone

    Frosinone, FR, 03031

  • Ospedale Civile di Legnano

    Legnano, MI

  • Ospedale S. Paolo

    Milan, MI, 20142

  • Ospedale L. Sacco

    Milan

  • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica

    Monteforte Irpino, AV, 83024

  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

    Naples, 80131

  • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

    Naples, 80131

  • Second University of Naples

    Naples

  • Divisione di Oncologia Medica, U.S.L.L. 13

    Noale, VE, 30033

  • Ospedale Civile Umberto I, Day Hospital Oncoematologico

    Nocera Inferiore, SA, 84014

  • Istituto Oncologico Veneto

    Padova, PD

  • Policlinico Universitario P. Giaccone

    Palermo, PA, 90100

  • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico

    Palermo, PA, 90146

  • Ospedale Santa Corona

    Pietre Ligure

  • Istituto Regina Elena, Divisione di Oncologia Medica

    Roma, 00144

  • Ospedale S. Giovanni Calibita Gatebenefratelli

    Roma, 00186

  • Ospedale San Camillo - Forlanini

    Rome

  • Azienda Ospedaliera Di Busto Arsizio

    Saronno

  • Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica

    Vicenza, VI, 36100

Other trials in Italy

About this study

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

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.

Read the 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)
Being tested
gemcitabine, prolonged continuous infusion gemcitabine, cisplatin, rofecoxib
Keywords
prolonged continuous infusion, Cox-2 inhibitors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00385606
Study groupRoleWhat they receive
cisplatino plus gemcitabineActive comparatorGemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.
Receives: Drug: gemcitabine; Drug: cisplatin
cisplatino plus gemcitabine plus rofecoxibExperimentalGemcitabina 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.
Receives: Drug: gemcitabine; Drug: cisplatin; Drug: rofecoxib
cisplatino plus gemcitabine 10 mg/m2/minExperimentalGemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.
Receives: Drug: prolonged continuous infusion gemcitabine; Drug: cisplatin
cisplatino plus gemcitabine 10 mg/m2/min plus rofecoxibExperimentalGemcitabina 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.
Receives: Drug: prolonged continuous infusion gemcitabine; Drug: cisplatin; Drug: rofecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the tolerability of three experimental treatment schedules

    adverse events according to CTCAE criteria

    Measured: at the end of each cycle of chemotherapy (every 3 weeks) until 21 days after the last treatment administrationministration

  2. To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy

    response rate according to RECIST criteria

    Measured: at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year).

  3. 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

    Measured: at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2006 (estimated)
  2. Study startJan 2003
  3. Primary completionDec 2005
  4. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00385606
Sponsor's protocol ID
GECO
Status last verified
Apr 2015
First submitted
10 Oct 2006
Last updated
23 Mar 2023
Results posted
No

Publications

  • 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.

    PubMed 17513173

  • Di 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.

    PubMed 25624439

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing gemcitabine, prolonged continuous infusion gemcitabine and cisplatin in people with Advanced Non-small Cell Lung Cancer, run by National Cancer Institute, Naples at 25 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the tolerability of three experimental treatment schedules (time frame: at the end of each cycle of chemotherapy (every 3 weeks) until 21 days after the last treatment administrationministration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00385606, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.

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