LOCALLY ADVANCED NSCLC CANCER MedDRA version: 15.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: ALIMTA*1FL POLV 500MG
Pharmaceutical Form: Powder for infusion
CAS Number: 137281-23-3
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: range
Concentration number: 4
Sponsors
UNIVERSITA' CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histological or cytological diagnosis of non-squamous NSCLC. • Inoperable neoplasia: inoperable IIIA, IIIB stages and intrathoracic relapse. • Induction platinum-based chemotherapy (3-5 cycles). • No previous radiotherapy treatment. • ECOG Performance Status 0-1. • Clinically measurable or evaluable disease. • At least 12 weeks life expectancy. • Adequate respiratory function: FEV1 > 1200 cc or > 45% of theoretical value; DLCO > 40% of theoretical value • Cardio-vascular diseases which do not contraindicate the treatment. • Adequate bone marrow function: WBC ? 4.0 × 103/L, ANC ? 2.0 × 109/L, PLT ? 100 × 109/L, Hgb ? 11 g/dl, Ht ? 32. • Creatinine clearance ? 45 ml/min (based on the Cockcroft and Gault formula) • Male or female 18 to 75 years old. • Informed written consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Inadequate hepatic function (bilirubin > 1.5 times ULN); abnormal PT, aPTT (upper than 1.5 times control values); ALT and AST > 3 times ULN • Inadequate renal function (serum creatinine > 1.5 times ULN and Creatinine Clearance: 40 mmHg • Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents 2 days before the day of, and 2 days after the dose of pemetrexed. If a patient is taking an NSAID (COX-2 inhibitors included) or salicylate with a long half-life (for example, naproxen, piroxicam, diflunisal, nabumetone, rofecoxib or celecoxib) it should not be taken 5 days before the dose of pemetrexed (8-day period for long-acting agents such as piroxicam), the day of, and 2 days after the dose of pemetrexed. • Clinically significant effusions for patients who develop or have baseline clinically significant pleural or peritoneal effusions ( on the basis of symptoms or clinical examination) before or during initiation of pemetrexed therapy, consideration should be given draining the effusion prior to dosing. However if, in the investigator's opinion, the effusion represents progression of disease, the patients should be discontinued from the study. • Inadequate hepatic function (bilirubin > 1.5 times ULN); abnormal PT, aPTT (upper than 1.5 times control values); ALT and AST > 3 times ULN • Inadequate renal function (serum creatinine > 1.5 times ULN and Creatinine Clearance: 40 mmHg • Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents 2 days before the day of, and 2 days after the dose of pemetrexed. If a patient is taking an NSAID (COX-2 inhibitors included) or salicylate with a long half-life (for example, naproxen, piroxicam, diflunisal, nabumetone, rofecoxib or celecoxib) it should not be taken 5 days before the dose of pemetrexed (8-day period for long-acting agents such as piroxicam), the day of, and 2 days after the dose of pemetrexed. • Clinically significant effusions for patients who develop or have baseline clinically significant pleural or peritoneal effusions ( on the basis of symptoms or clinical examination) before or during initiation of pemetrexed therapy, consideration should be given draining the effusion prior to dosing. However if, in the investigator's opinion, the effusion represents progression of disease, the patients should be discontinued from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study primary endpoint is to determine the MTD of weekly pemetrexed in combination to radiotherapy in NSCLC non-squamous patients in inoperable IIIA, IIIB stage and intrathoracic relapse pre-treated with chemotherapy.;Secondary Objective: • response rate to the integrated treatment as measured by RECIST • nature and degree of toxicity • local control;Primary end point(s): Study primary endpoint is to determine the MTD of weekly pemetrexed in combination to radiotherapy in NSCLC non-squamous patients in inoperable IIIA, IIIB stage and intrathoracic relapse pre-treated with chemotherapy.;Timepoint(s) of evaluation of this end point: 18 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • response rate to the integrated treatment as measured by RECIST • nature and degree of toxicity • local control;Timepoint(s) of evaluation of this end point: 18 MONTHS | — |
Countries
Italy
Contacts
Public ContactUNITA' OPERATIVA DI RADIOTERAPIA
UNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
Outcome results
None listed