Multicentre Randomised Phase II Trial of Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients (=/> 70 Years) With Advanced Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 260
- Locations
- 39
- Primary Endpoint
- Evaluation of the progression free survival rate with the first-line therapy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
A
Intervention: Erlotinib (Drug)
B
Intervention: Vinorelbine and Carboplatin (Drug)
Outcomes
Primary Outcomes
Evaluation of the progression free survival rate with the first-line therapy
Time Frame: Tumour assessment every other cycle (interval of 42 days)
Secondary Outcomes
- 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)