Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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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.

Official Title
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Multicentre Randomised Phase II Trial of Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients (=/> 70 Years) With Advanced Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Erlotinib
* Drug: Vinorelbine and Carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Erlotinib<br>* Erlotinib 150 mg, p.o., once daily<br>* Other names: Tarceva;|
| Active Comparator: B<br> | Drug: Vinorelbine and Carboplatin<br>* 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<br>* Other names: Carboplat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the progression free survival rate with the first-line therapy |  | Tumour assessment every other cycle (interval of 42 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of remission |  | Tumour assessment every other cycle (interval of 42 days) | 
| 1-year survival |  | 1 year | 
| Overall survival |  | End of study | 
| Response rate (CR/RR) |  | Tumour assessment every other cycle (interval of 42 days) | 
| Quality of life, improvement of symptoms (FACT-L) |  | Every other cycle (interval of 42 days) | 
| Simplified Charlsons´Comorbidity Score |  | baseline | 
| Safety and Tolerability |  | continously | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Elderly patients