Trial | NCT00678964  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    260
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 Started
Jun 30
2006
Primary Completion
Nov 30
2008
Anticipated
Last Update
May 16
2008
Estimate

Drug Erlotinib

Erlotinib 150 mg, p.o., once daily

  • Other names: Tarceva

Drug Vinorelbine 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

  • Other names: Navelbine, Carboplat

A Experimental

B Active Comparator

Criteria 

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
No Results Posted