Vandetanib, Carboplatin, and Paclitaxel in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer Read More

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:

  • Stage IB or II disease
  • T3, N0-1 disease (stage IIIA)
• Deemed a surgical candidate
• No prior lung cancer (NSCLC or small cell lung cancer)

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the investigator, would preclude study compliance
• No peripheral neuropathy ≥ grade 2
• No hemoptysis within the past 12 weeks
• No spontaneous bleeding within the past 12 weeks
• No clinically significant cardiac event (e.g., NYHA class II-IV heart disease, myocardial infarction) within the past 3 months

• No history of asymptomatic sustained ventricular tachycardia or arrhythmia that is symptomatic or requires treatment, including any of the following:

  • Multifocal premature ventricular contractions
  • Bigeminy
  • Trigeminy
  • Ventricular tachycardia

  • Uncontrolled atrial fibrillation

    • Atrial fibrillation controlled with medication allowed
• No history of QTc prolongation as a result from other medication that required discontinuation of that medication
• No congenital long QT syndrome or first-degree family relative with an unexplained death before the age of 40
• No left bundle branch block

• No QTc with Bazett's correction that is unmeasurable or QTc ≥ 480 milliseconds on screening ECG

  • Patients with QTc ≥ 480 milliseconds on screening ECG may have ECG repeated twice

    • Average QTc from the 3 screening ECG's must be < 480 milliseconds
• No uncontrolled hypertension (systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg)
• No active diarrhea or active gastrointestinal disease that may affect the absorption of study drugs or ability to tolerate study drugs
• No other malignancy within the past 3 years except in situ cervical carcinoma or adequately treated basal cell or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since major surgery and recovered
• No prior carboplatin, paclitaxel, or vandetanib
• More than 30 days since prior investigational agents

• More than 2 weeks since prior and no concurrent drugs that induce CYP3A4 including, but not limited to, any of the following:

  • Rifampin
  • Phenytoin
  • Carbamazepine
  • Barbiturates
  • Hypericum perforatum (St. John's wort)
• No medication that may cause QTc prolongation or induce torsades de pointes for 2 weeks prior to beginning study treatment, during, and for 2 weeks after completion of study treatment
• No concurrent combination antiretroviral treatment for HIV-positive patients
• No other concurrent investigational agents