A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.

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

Details

• Lead Sponsor: Tony Bekaii-Saab
• Collaborator: Roche Pharma AG
• Treatments: Capecitabine; Docetaxel

Criteria

Inclusion Criteria:

• Must have advanced NSCLC

• No prior chemotherapy

• Eastern Cooperative Oncology Group(ECOG)Performance Status:0 or 1

• Must have measurable disease (RECIST criteria)

• life expectancy of at least 12 weeks

• adequate organ function including

Exclusion Criteria:

• Pregnant or lactating women

• Psychiatric disorders that would interfere w/consent or follow-up

• Patients with uncontrolled diabetes mellitus, defined as random blood sugar > 250mg/dL.