Study Design: Phase II trial, open label, non-randomized and multicenter.
Expected total enrollment: 46
Study start: January, 2006
Study completation: January, 2008
Age
18–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 years.
Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
Measurable disease.
Written informed consent must be obtained prior to the inclusion into the trial.
Karnofsky performance status of 80%.
Patients must have been treated with no prior chemotherapy or radioterapy.
Patients must have adequate bone marrow, liver and renal function.
* Bone Marrow: WBC \> 3000 x 103/mm3,
* Platelets \> 100 x 103/mm3,
* Hgb \> 10.0 gm/dl,
* ANC \>1500 x 103/mm3,
* Hepatic:Bilirubin \< 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase \< 5 x normal,
* Renal:Creatinine \< 1.5 mg/dl (132 µmol/l).
You may not be if
Female patients who are pregnant or lactating.
Patients who have used other investigational agents within 21 days prior to study entry.
Patients who have received prior treatment with erlotinib or other anti-EGFR agent.
Significant comorbidity.
Clareo Health | Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer