Advanced Non-small Cell Lung Cancer
Conditions
Keywords
prolonged continuous infusion, Cox-2 inhibitors
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)
Interventions
Sponsors
National Cancer Institute, Naples
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
Italy
Outcome results
None listed