Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC, Elderly patients
Brief summary
60% of all malignant diseases occur in patients who are 65 years or older. For these patients, aggressive treatments are often not suitable due to reduced life-expectancy, reduced general condition, comorbidities, and reduced vital functions which can lead to increased adverse effects of chemotherapy. Therefore, it is important to investigate alternative therapy options for elderly patients. Erlotinib is an orally applied medication which is associated with reasonable toxicity. This targeted agent may prove an effective and well-tolerated first-line therapy in elderly patients with advanced non small cell lung cancer. Therefore, the aim of this study is to investigate the progression-free survival of the combination of vinorelbine and carboplatin in comparison to erlotinib. Given that there will be no significant reduction of efficiency this may provide elderly patients of more than 70 years of age with an active oral substance without subjecting them to the sometimes severe adverse effect of the chemotherapy.
Interventions
DRUGErlotinib
Erlotinib 150 mg, p.o., once daily
DRUGVinorelbine and Carboplatin
Vinorelbine 25 mg/m2, i.v., day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v., day 1 of every cycle
Sponsors
LungenClinic Grosshansdorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytological proven NSCLC, stage lll b (with pleural effusion) or stage lV. * Tumour is locally advanced and not suitable for surgery and radiotherapy is not indicated. * Neither cytostatic nor immunological pre-treatment * Age \>70 years * At least one measurable lesion (RECIST criteria) that was not previously irradiated * ECOG Performance Status 0-1 * Life expectancy \> 3 month * Adequate bone marrow function: ANC \> 1.5 x 109/L, Platelets \> 100 x 109/L * Adequate liver function: Total Bilirubin \< 1.5 x ULN, GOT/GPT\< 3 x ULN (existent liver metastases \< 5 x ULN) * Adequate renal function:creatinine clearance \> 45 ml/min (calculated according to Cockroft-Gault) * Fertile men must agree to use an effective method of birth control while participating in this study * Signed written informed consent
Exclusion criteria
* Uncontrolled metastasis in the CNS * Acute, heavy uncontrolled infection * Any other serious concomitant disease or medical condition, which could interfere with participating in this study * Severe hypersensitivity to Erlotinib or any other component * Hypersensitivity to Carboplatin and/or other platinum compounds * Hypersensitivity to Vinorelbin or other Vinca-alkaloids * Patients with a history of other active malignancy in the past 5 years (with the exception of carcinoma in situ of the cervix, non melanomatous skin cancers or local prostate carcinoma that was surgically treated successfully) are excluded. * Participation in another clinical trial with any investigational drug at the same time or within 30 days prior to registration * Psychological, familial, social or geographical situations limiting the compliance with the study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the progression free survival rate with the first-line therapy | Tumour assessment every other cycle (interval of 42 days) |
Secondary
| Measure | Time frame |
|---|---|
| 1-year survival | 1 year |
| Overall survival | End of study |
| Response rate (CR/RR) | Tumour assessment every other cycle (interval of 42 days) |
| Duration of remission | Tumour assessment every other cycle (interval of 42 days) |
| Simplified Charlsons´Comorbidity Score | baseline |
| Safety and Tolerability | continously |
| Quality of life, improvement of symptoms (FACT-L) | Every other cycle (interval of 42 days) |
Countries
Germany
Outcome results
None listed