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
18 Years
70 Years
Both
Advanced Non-Small Cell Lung Cancer
Trial Information
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 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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the tolerability of three experimental treatment schedules
Principal Investigator
Cesare Gridelli, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
San Giuseppe Moscati Hospital, Avellino, Italy
Authority:
Italy: Ethics Committee
Study ID:
GECO
NCT ID:
NCT00385606
Start Date:
January 2003
Completion Date:
Related Keywords:
- Advanced Non-Small Cell Lung Cancer
- prolonged continuous infusion
- Cox-2 inhibitors
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
