Enrolment of old or unfit patient with age over 70, with Non Small Cell Lung Cancer, not operable stage IIIA, IIIB, IV MedDRA version: 6.1 Level: PT Classification code 10061873
Conditions
Interventions
Trade Name: TAXOTERE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Docetaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: GEMZ
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hystological or cytological diagnosis of NSCLC; Stage IIIA, IIIB good prognosis and bad prognosis ( N3 sovraclavear and/or neoplastic or suspected neoplastic pleural effusion); and IV Presence at least a measurable lesion second criteria RECIST or, in absence of measurable lesions, presence of valued lesions; the lesions target must not be irradiated or, if irradiated, must be in progression. Patients, that have performed the surgery, could be enrolled if recidivist or with residual disease after the primary surgery; ECOG Performance Status 0-2; Age >= 70 years; Not previous chemotherapy; Life expectancy of at least 12 weeks; Adeguate bone marrow reserve: granulocytes >= 1500; platelets >= 100.000; hemoglobin >=10 gr/dl; ? Normal renal function (creatinin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Active or uncontrolled infections Hystory present or past of allergy Significant cardiovascular pathology Uncontrolled Diabetes Mellitus Second tumor within previous 5 years (except carcinoma in situ of the portio, cutaneous carcinoma, superficial carcinoma of the blister with radical treatment) Impossibility to perform a follow-up quickly if a significant toxicity is present
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity and the toxicity of docetaxel and gemcitabine every 15 days;Secondary Objective: median survival, at 6, 12 and 24 months quality of life and control the symptoms in the patient treated the efficiency of the geriatric multidimensional evaluation;Primary end point(s): To evaluate the activity and the toxicity of docetaxel and gemcitabine every 15 days | — |
Countries
Italy
Outcome results
None listed