Study of Vandetanib Combined With Chemotherapy to Treat Advanced Non-small Cell Lung Cancer
Condition: Lung Cancer; Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: vandetanib induction; Docetaxel; Carboplatin; Placebo; Vandetanib maintenance
Intervention description: 100 mg daily by mouth; (75mg/m2) IV (in the vein) on day 1 of a 21-day cycle for 4 cycles or until disease progression; IV (in the vein) to area under the curve (AUC) of 6 on day 1 of a 21 day cycle, for 4 cycles or until disease progression; 300 mg daily by mouth
Intervention MeSH terms: Carboplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stage IIIB Non Small Cell Lung Cancer; Stage IV Non Small Cell Lung Cancer; Vandetanib; Docetaxel plus carboplatin

Summary:

      It has been shown in previous studies that the ability to treat lung cancer could be
      significantly improved by not only targeting the tumor cells directly with chemotherapy, but
      also by cutting off the blood supply to the cancer cells. Blood vessels that supply the tumor
      are formed through a process called angiogenesis. Vandetanib is an investigational drug that
      acts by producing what is called an anti-angiogenic effect. An Anti-angiogenic effect is able
      to inhibit the development of new blood vessels required by tumors to survive by blocking the
      growth factors needed to form new blood vessels.

      The purpose of this study is to determine if the addition of vandetanib to a standard
      chemotherapy regimen will slow or stop the growth of the cancer for a longer period of time
      compared to the time period generally gained from the use of standard chemotherapy alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed non-small cell lung cancer

          -  Advanced disease (stage IIIB disease [malignant pleural or pericardial effusion seen
             on CT or Chest X-ray, any N, M0] or stage IV disease [Any T, any N, M1: distant
             metastases]) that is primary or recurrent

          -  Measurable disease according to the RECIST criteria

          -  ECOG Performance Status 0 or 1

          -  Adequate organ function, as evidenced by ALL the following

          -  Absolute neutrophil count (ANC) ≥ 1500/mm³ and platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9 gm/dL

          -  Total bilirubin ≤ 1 X institutional ULN; if patient has Gilbert's disease, then
             patient must have isolated hyperbilirubinemia (e.g. no other liver function test
             abnormality), with maximum bilirubin ≤ 2 X institutional ULN.

          -  AST, ALT and alkaline phosphatase (Alk Phos) must be ≤ 1.5 ULN

          -  Creatinine ≤ 1.5 X institutional ULN or calculated creatinine clearance ≥ 60 ml/min

          -  Potassium between 4 mEq/L and institutional ULN (supplementation may be used),

          -  Calcium (ionized or adjusted for albumin)within institutional normal limits

          -  Magnesium within institutional normal limits (supplementation may be used)

          -  No prior cytotoxic chemotherapy or targeted therapy for advanced or metastatic disease
             (Prior adjuvant therapy for lung cancer allowed if completed > 1 year prior to
             registration)

          -  Able to take oral medication

        Exclusion Criteria:

          -  Myocardial infarction, superior vena caval syndrome, NYHA classification of heart
             disease ≥ 2 within the 3 months prior to entry

          -  History of an uncontrolled or recurrent ventricular, supraventricular or nodal
             arrhythmia that requires treatment

          -  Hypertension not controlled by medication

          -  Peripheral or sensory neuropathy > grade 1

          -  Known hypersensitivity to carboplatin or docetaxel

          -  Active infection