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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

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 schedules

To 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

Page last updated: August 23, 2015

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