Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC
- Conditions
- Advanced Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00385606
- Lead Sponsor
- 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.
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description cisplatino plus gemcitabine 10 mg/m2/min prolonged continuous infusion gemcitabine Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles. cisplatino plus gemcitabine 10 mg/m2/min plus rofecoxib prolonged continuous infusion gemcitabine 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. cisplatino plus gemcitabine cisplatin Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles. cisplatino plus gemcitabine 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. cisplatino plus gemcitabine plus rofecoxib gemcitabine 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. cisplatino plus gemcitabine plus rofecoxib cisplatin 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. cisplatino plus gemcitabine 10 mg/m2/min cisplatin Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles. cisplatino plus gemcitabine plus rofecoxib 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. cisplatino plus gemcitabine 10 mg/m2/min plus rofecoxib cisplatin 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. cisplatino plus gemcitabine 10 mg/m2/min plus rofecoxib 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.
- Primary Outcome Measures
Name Time Method To evaluate the tolerability of three experimental treatment schedules at the end of each cycle of chemotherapy (every 3 weeks) until 21 days after the last treatment administrationministration adverse events according to CTCAE criteria
To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year). response rate according to RECIST criteria
To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine vs standard infusion, in combination with cisplatin at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year). response rate according to RECIST criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Ospedale S. Paolo
🇮🇹Milano, MI, Italy
Ospedale Umberto di Frosinone
🇮🇹Frosinone, FR, Italy
Ospedale L. Sacco
🇮🇹Milano, Italy
Second University of Naples
🇮🇹Napoli, Italy
Azienda Ospedaliera Di Busto Arsizio
🇮🇹Saronno, Italy
Istituto Oncologico Veneto
🇮🇹Padova, PD, Italy
Ospedale San Camillo - Forlanini
🇮🇹Rome, Italy
Ospedale Civile di Legnano
🇮🇹Legnano, MI, Italy
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
🇮🇹Vicenza, VI, Italy
Policlinico Universitario P. Giaccone
🇮🇹Palermo, PA, Italy
Ospedale S. Giovanni Calibita Gatebenefratelli
🇮🇹Roma, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
🇮🇹Palermo, PA, Italy
Ospedale Civile Umberto I, Day Hospital Oncoematologico
🇮🇹Nocera Inferiore, SA, Italy
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
🇮🇹Monteforte Irpino, AV, 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 Mariano Santo, U.O. di Oncologia Medica
🇮🇹Cosenza, CS, Italy
Ospedale A. Cardarelli
🇮🇹Campobasso, CB, Italy
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
🇮🇹Acquaviva delle Fonti, BA, Italy
Divisione di Oncologia Medica, U.S.L.L. 13
🇮🇹Noale, VE, Italy
Istituto Regina Elena, Divisione di Oncologia Medica
🇮🇹Roma, Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
🇮🇹Napoli, Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
🇮🇹Napoli, Italy
Ospedale Santa Corona
🇮🇹Pietre Ligure, Italy