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

NCT ID: NCT00385606

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2006-07-31

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)

Conditions

Advanced Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cisplatino plus gemcitabine

Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.

Group Type: ACTIVE_COMPARATOR

gemcitabine

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

cisplatino plus gemcitabine plus rofecoxib

Gemcitabina 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.

Group Type: EXPERIMENTAL

gemcitabine

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

rofecoxib

Intervention Type: DRUG

cisplatino plus gemcitabine 10 mg/m2/min

Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.

Group Type: EXPERIMENTAL

prolonged continuous infusion gemcitabine

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

cisplatino plus gemcitabine 10 mg/m2/min plus rofecoxib

Gemcitabina 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.

Group Type: EXPERIMENTAL

prolonged continuous infusion gemcitabine

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

rofecoxib

Intervention Type: DRUG

Interventions

gemcitabine

Intervention Type: DRUG

prolonged continuous infusion gemcitabine

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

rofecoxib

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cesare Gridelli, M.D.

Role: PRINCIPAL_INVESTIGATOR

San Giuseppe Moscati Hospital, Avellino, Italy

Francesco Perrone, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute Naples, Italy

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

Milan, 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

Padua, 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

Milan, , 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

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 17513173 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25624439 (View on PubMed)

Other Identifiers

GECO

Identifier Type: -

Identifier Source: org_study_id