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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

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)

Intervention(s) in this Clinical Trial

• Drug: gemcitabine
• Drug: prolonged continuous infusion gemcitabine
• Drug: cisplatin
• Drug: rofecoxib

Primary Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Cancer Institute, Naples

Overall Clinical Trial Officials and Contacts

Cesare Gridelli, M.D. Principal Investigator San Giuseppe Moscati Hospital, Avellino, Italy  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00385606

Study ID Number: GECO

ClinicalTrials.gov Identifier: NCT00385606

Health Authority: Italy: Ethics Committee