Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: ZD6474, Vandetanib; Placebo to Match ZD6474, Vandetanib; Gemcitabine
Intervention description: 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first; 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first; administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle UP to 6 cycles or UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: ZD6474; VANDETANIB; ZACTIMA; ADVANCED; NSCLC; LUNG CANCER; ELDERLY PATIENTS; GEMCITABINE; PHASE II; RANDOMIZED; DOUBLE-BLIND; histologically or cytologically-confirmed advanced (stage IIIB with supraclavicular lymph node metastases or pleural effusion or stage IV) NSCLC

Summary:

      The primary objective of this study is to demonstrate an improvement in Progression-Free
      Survival (PFS) for the combination of vandetanib plus gemcitabine compared with gemcitabine
      plus placebo in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with
      advanced NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic confirmation of advanced NSCLC (stage IIIB with
             supraclavicular lymph node metastases or pleural effusion or stage IV) on entry into
             study

          -  One or more measurable lesions at least 10 mm in the longest diameter (LD) by spiral
             CT scan or 20 mm with conventional techniques according to RECIST criteria

          -  Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3
             months before the trial entry is accepted).

          -  Female or male aged 70 years or above

        Exclusion Criteria:

          -  Patients must not have received prior anti-cancer therapy except in the adjuvant
             setting

          -  Inadequate end-organ function or Evidence of severe or uncontrolled systemic disease
             or any concurrent condition which in the Investigator's opinion makes it undesirable
             for the patient to participate in the trial

          -  Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC]
             syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within
             3 months before entry, or presence of cardiac disease that in the opinion of

          -  History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on
             screening ECG