Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer
Conditions
Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Tarceva (erlotinib)
Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Grupo Gallego de Cancer de Pulmon
Santiago de Compostela, A Coruña, Spain
Status: Recruiting
Contact: Joaquin Casal, MD - joaquin.casal.rubio@sergas.es
Start Date
January 2006
Sponsors
Grupo Gallego de Cancer de Pulmon
Source
Grupo Gallego de Cancer de Pulmon
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page