Clinical trial NCT00459121 (phase 2, status: terminated)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboplatin, paclitaxel, zactima
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, COC1=C(OCC2CCN(C)CC2)C=C2N=CN=C(NC3=C(F)C=C(Br)C=C3)C2=C1
Eligibility criteria:

        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