Clinical trial NCT00753714: Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
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
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 124
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Oct 2008- dec 2011
Secondary outcomes:
measure: Overall Survival
timeFrame: Oct 2008- dec 2011
measure: Overall Objective Response
timeFrame: Oct 2008- dec 2011
measure: Duration of Response
timeFrame: Oct 2008- dec 2011
measure: The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine
timeFrame: Oct 2008- Dec 2011
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Research Site
state: (fc)
city: Avellino
country: Italy
facility: Research Site
state: AV
city: Bari
country: Italy
facility: Research Site
state: BA
city: Treviglio
country: Italy
facility: Research Site
state: BG
city: Bologna
country: Italy
facility: Research Site
state: BO
city: Genova
country: Italy
facility: Research Site
state: GE
city: Taormina
country: Italy
facility: Research Site
state: ME
city: Milano
country: Italy
facility: Research Site
state: MI
city: Perugia
country: Italy
facility: Research Site
state: PG
city: Ravenna
country: Italy
facility: Research Site
state: RA
city: Trento
country: Italy
facility: Research Site
state: TN
city: Orbassano
country: Italy
facility: Research Site
state: TO
city: Udine
country: Italy
facility: Research Site
state: UD
city: Padova
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Gridelli C. Treatment of advanced non small-cell lung cancer in the elderly: from best supportive care to the combination of platin-based chemotherapy and targeted therapies. J Clin Oncol. 2008 Jan 1;26(1):13-5. doi: 10.1200/JCO.2007.14.1820. No abstract available.