A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression.

Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.

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

Details

• Lead Sponsor: University of Utah
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Performance status 0-1.

• Weight Loss < 10% in preceding 3 months

• Age 18 years and older.

• Adjuvant chemotherapy allowed if > 6 months from protocol entry

• Adequate Organ Function

• Liver enzymes < 2X normal, bilirubin = normal

• Oxygen saturation> 89% on room air unless chronically oxygen dependent (not cancer related)

• Creatinine <2.0 mg

Exclusion Criteria:

• Not pregnant or lactating.

• No Clinical Brain Metastases

• No prior chemotherapy for systemic disease

• Imminent need for chemotherapy for impending organ dysfunction is not allowed