Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine

Non Small Cell Lung Cancer Clinical Trial

— ZELIG  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753714
• Other study ID #: D4200L00012
• Secondary ID: EUDRACT n° 2007-
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2008
• Last updated: January 30, 2013
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• ZD6474, Vandetanib
100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
• Placebo to Match ZD6474, Vandetanib
100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
• Gemcitabine
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

Locations

Country	Name	City	State
Italy	Research Site	Avellino	AV
Italy	Research Site	Bari	BA
Italy	Research Site	Bologna	BO
Italy	Research Site	Genova	GE
Italy	Research Site	Meldola	(fc)
Italy	Research Site	Milano	MI
Italy	Research Site	Orbassano	TO
Italy	Research Site	Padova
Italy	Research Site	Perugia	PG
Italy	Research Site	Ravenna	RA
Italy	Research Site	Roma
Italy	Research Site	Taormina	ME
Italy	Research Site	Trento	TN
Italy	Research Site	Treviglio	BG
Italy	Research Site	Udine	UD

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		Oct 2008- dec 2011	No
Secondary	Overall Survival		Oct 2008- dec 2011	No
Secondary	Overall Objective Response		Oct 2008- dec 2011	No
Secondary	Duration of Response		Oct 2008- dec 2011	No
Secondary	The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine	The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes	Oct 2008- Dec 2011	Yes