Lung Cancer Clinical Trial
Official title:
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)
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,
such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. Giving vandetanib together
with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal
tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving vandetanib together with carboplatin
and paclitaxel works in treating patients with stage I, stage II, or stage III non-small cell
lung cancer that can be removed by surgery.
OBJECTIVES:
Primary
- 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 cancer.
Secondary
- 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.
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