Know Cancer

or
forgot password

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


Phase 2
70 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of the progression free survival rate with the first-line therapy

Outcome Time Frame:

Tumour assessment every other cycle (interval of 42 days)

Safety Issue:

No

Principal Investigator

Martin Reck, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Grosshansdorf

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EudraCT 2005-005827-32

NCT ID:

NCT00678964

Start Date:

June 2006

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Elderly patients
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location