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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1
Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1.
Zactima- 100 mg orally daily, starting on day 1 of cycle 1.
Neoadjuvant surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Complete Resection (R0) Rate
Time frame: Following three cycles of pre-operative zactima and carboplatin/paclitaxel
Post-Operative Mortality Rate
Time frame: at 30 days
Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy
Serum chemistry includes Albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, glucose, potassium, total protein, SGOT \[AST\], SGPT \[ALT\], sodium, laboratory tests should be done on a weekly basis for the first cycle. After the first cycle laboratory tests should be done within 72 hours of each dose of carboplatin/paclitaxel.
Time frame: Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel
Assess the Clinical Response Rate of the Proposed Pre-operative Regimen
Patients will undergo tumor evaluation when all of the three cycles have been completed unless the treating physician has concerns regarding tumor progression. If the patient has undergone tumor evaluation prior to the last cycle the patient will require repeat tumor assessment within 4 weeks of completion of the last cycle of therapy
Time frame: End of three cycles of treatment
Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen.
Evaluation of the number of patients who have no evidence of tumor in the resected tumor.
Time frame: 30 days post surgery
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