metastatic inoperable tumour for NSCLC MedDRA version: 15.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Dalacin C
Pharmaceutical Form: Capsule, hard
Trade Name: ISORIAC 20 mg
Pharmaceutical Form: Capsule, soft
Trade Name: TARCEVA
Pharmaceutical Form: Film-coated tablet
Sponsors
A.O. SAN GERARDO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: non small cell lung cancer histological diagnosis; age > 18 years; PS 0-2; Measurable or evaluable illness; Average marrow reserve; Adequate liver and renal functionality; more than one previous chemio treatments; previous treatment completed by at least 3 weeks; life expectancy > 3 months adequate geographical closeness written informed consent; negative pregnancy test radiant treatment allowed for palliative intent only if the bone marrow field is radiated =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: symptomatic cerebral secondaries not controlled by an adequate steroid and/or antiepileptic therapy ; concomitant curative lung radiation therapy serious concomitant illnesses not compliant to the treatment plan enrolled in other studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether or not the prescription of the experimental treatment changes the incidence of the cutaneous rash in the first 30 days of treatment with erlotinib;Secondary Objective: To evaluate any collateral effects of the preventive treatment. To evidence the curative effectiveness of the experimental treatment in both groups of patients after the onset of rash. To evaluate erlotinib’s activity in the two arms of treatment.;Primary end point(s): Possible cutaneous rash onset of grade > 2 in the first 30 days of treatment;Timepoint(s) of evaluation of this end point: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the plasmatic ranges for triglycerides, cholesterol and liver tests Calculation of the percentage of solved cutaneous rash (from grade > 2 to grade < 1). Evaluate the objective response of the treatment with erlotinib. ;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Italy
Contacts
Public ContactMedical Oncology –Trial Office
A.O. SAN GERARDO
Outcome results
None listed