Assessment of Feasibility and Safety of the Addition of ZD6474 (Zactima) to Carboplatin and Paclitaxel Administered Neo-Adjuvantly in Stage IB, II and T3, N1 Non-Small Cell Lung Cancer (NSCLC)
- Determine the feasibility of neoadjuvant vandetanib in combination with carboplatin and
paclitaxel in patients with resectable stage IB, II, or IIIA non-small cell lung
- Assess the 30-day postoperative mortality rate in these patients.
- Assess the toxicity of this regimen in these patients.
- Determine the percentage of patients who complete all planned courses of therapy.
- Assess the clinical response rate in patients treated with this regimen.
- Assess the pathologic complete response rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral vandetanib once daily on days 1-21. Patients also receive paclitaxel
IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for
up to 3 courses.
Patients undergo surgery at least 3 weeks after the last course of chemotherapy.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Resection (R0) Rate
Following three cycles of pre-operative zactima and carboplatin/paclitaxel
Shirish M. Gadgeel, MD
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|