Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Gallego de Cancer de Pulmon
• Treatments: Erlotinib Hydrochloride

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.