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Phase II, Randomised, Double-blind, Two-arm, Parallel Study of Vandetanib (ZACTIMA™ , ZD6474) Plus Gemcitabine (Gemzar® ) or Gemcitabine Plus Placebo as First Line Treatment of Advanced (Stage IIIB or IV) Non Small Cell Lung Cancer (NSCLC) Elderly Patients.


Phase 2
70 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

Thank you

Trial Information

Phase II, Randomised, Double-blind, Two-arm, Parallel Study of Vandetanib (ZACTIMA™ , ZD6474) Plus Gemcitabine (Gemzar® ) or Gemcitabine Plus Placebo as First Line Treatment of Advanced (Stage IIIB or IV) Non Small Cell Lung Cancer (NSCLC) Elderly Patients.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

Oct 2008- dec 2011

Safety Issue:

No

Principal Investigator

Cesare Gridelli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

A.O. S.Giuseppe Moscati di Avellino - AVELLINO ITALY

Authority:

Italy: Ethics Committee

Study ID:

D4200L00012

NCT ID:

NCT00753714

Start Date:

October 2008

Completion Date:

December 2011

Related Keywords:

  • Non Small Cell Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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