Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC

National Cancer Institute, Naples400 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Advanced Non-small Cell Lung Cancer

Interventions

gemcitabineDRUG

prolonged continuous infusion gemcitabineDRUG

cisplatinDRUG

rofecoxibDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 (25)

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica

Monteforte Irpino, AV, Italy

Outcomes

Primary Outcomes

To evaluate the tolerability of three experimental treatment schedules

adverse events according to CTCAE criteria

Time frame: at the end of each cycle of chemotherapy (every 3 weeks) until 21 days after the last treatment administrationministration

To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy

response rate according to RECIST criteria

Time frame: at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year).

To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine vs standard infusion, in combination with cisplatin

response rate according to RECIST criteria

Time frame: at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.