Status:
UNKNOWN
Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
LungenClinic Grosshansdorf
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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, c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00678964
Start Date
June 1 2006
Last Update
May 16 2008
Active Locations (40)
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1
Gemeinschaftspraxis
Augsburg, Germany, 86150
2
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
3
Charité - Campus Benjamin Franklin
Berlin, Germany, 12200
4
Helios Klinikum Emil von Behring
Berlin, Germany, 14165