Elderly patients form an increasing proportion of the lung cancer population. The median age of patients with a bronchial cancer is 68 years old (Gridelli et al., 1997). In a more recent study, Ng et al. (2004) showed that 46% of patients are over the age of 70 when the NSCLC is diagnosed. Around 37% of patients aged over 70 are not treated, in contrast with younger patients. MedDRA version: V5 Level: LLT Classification code 10029514
Conditions
Interventions
Trade Name: TAXOTERE®
Product Name: TAXOTERE®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: docetaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Fédération Nationale des Centres de Lutte Contre le Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged = 70. 2. Histologically or cytologically confirmed non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or combinations of these non-small cell histologies) of TNM Stage IV or Stage IIIB (pleural T4) that has never been treated by chemotherapy. Including relapse in a non-irradiated area of a previously resected or irradiated primary lung cancer – if there is histological or cytological proof of relapse. 3. Metastatic disease measurable by scan or MRI (RECIST criteria). 4. First-line metastatic chemotherapy. 5. Satisfactory autonomy of daily activity: IADL = 4 or ADL = 4. 6. Satisfactory haematological and hepatic function: Hb >10g/dL, neutrophil count > 1.5x109/L, platelets > 100x109/L, transaminases 0.15g/l. 8. Creatinine clearance > 30 ml/min calculated according to Cokroft's formula. 9. Signed informed consent. 10. Life expectancy > 3 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any patient who does not fulfil the inclusion criteria. 2. Symptomatic brain metastasis. 3. Peripheral neuropathies of grade 2 or greater. 4. Other serious illness or medical conditions, including: - congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from trial entry, non-controlled hypertension or high-risk non-controlled arrhythmia, - history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would hamper understanding and giving informed consent, - active non-controlled infection, - active peptic ulcer, non-controlled diabetes mellitus, inflammatory bowel disease. 5. Concurrent treatment with any other anti-cancer therapy. 6. Chronic treatment with corticosteroids unless initiated > 6 months prior to trial entry and at low dose (£ 20 mg methylprednisolone per day or equivalent). 7. Absolute contraindications for the use of corticosteroids. 8. Past or current history of neoplasm other than non-small cell lung cancer, except: - basal cell carcinoma of the skin, - in situ carcinoma of the cervix, - other cancer curatively treated and with no evidence of disease for at least 5 years. 9. Patients exhibiting a GDS (geriatric depression scale) score = 12/15. 10. History of hypersensitivity to docetaxel or drugs formulated with polysorbate 80. 11. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls. 12. Concurrent treatment with other investigational drugs. Active treatment as part of another clinical trial within 30 days prior to trial entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess: - Impact of chemotherapy on autonomy of activity in instrumental life, defined according to the IADL index on 8 items during treatment (2nd, 4th and 6th cycle), at 6 and 12 months. ;Secondary Objective: To assess: - Response rate according to RECIST criteria (Therasse et al., 2000) after first line docetaxel administered bi-weekly, - Overall survival, progression-free survival, - Impact of chemotherapy on autonomy of activity in instrumental life, defined according to ADL index using 6 items, - Impact of chemotherapy on mood status according to the GDS (geriatric depression scale), - Toxicity defined according to the NCI-CTC criteria. ;Primary end point(s): To assess: - Percentage of patients that maintain their autonomy in all instrumental activities of daily living as defined in the IADL assessment scale, on 8 items during treatment (2nd, 4th and 6th cycle), at 6 and 12 months. | — |
Countries
United Kingdom
Outcome results
None listed