Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV NSCLC

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, single institution, phase II study of Sorafenib in combination with docetaxel and carboplatin in patients with advanced non-small cell lung cancer. Docetaxel and carboplatin will be given on day 1 of every three week cycle. Patients will take Sorafenib twice a day on the 1st day of treatment and continue to take the medication every day until progression of disease, prohibitive toxicity, or patient withdrawal from the study. Chemotherapy courses will repeat every 21 days in the absence of disease progression or unacceptable toxicity for a total of four cycles.

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

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Carboplatin; Docetaxel; Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed NSCLC with clinical or radiological evidence of advanced disease (Stage IIIB/IV)

• Uni-dimensionally measurable disease

• Age => 18 years

• ECOG performance status of 0-1

• Life expectancy > 3 months

Exclusion Criteria:

• Small-cell or mixed histologies including a small cell component

• Prior chemotherapy, biotherapy, radiotherapy to an area of measurable disease

• Patients with peripheral neuropathy grade => 2