Non-Small Cell Lung Cancer
Conditions
Brief summary
A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated. STUDY OBJECTIVES Primary: Objective response rate Secondary: Progression free survival, Overall survival and Safety of Tarceva
Detailed description
Study Design: Phase II trial, open label, non-randomized and multicenter. Expected total enrollment: 46 Study start: January, 2006 Study completation: January, 2008
Interventions
Sponsors
Grupo Gallego de Cancer de Pulmon
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
| Overall survival | — |
| Safety of Tarceva | — |
Countries
Spain
Contacts
Primary ContactJoaquin Casal, MD
Outcome results
None listed