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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
ZD6474, Vandetanib
Placebo to Match ZD6474, Vandetanib
Gemcitabine
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring 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

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.

Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Overall Survival
Overall Objective Response
Duration of Response
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

Full Information

First Posted
September 15, 2008
Last Updated
August 30, 2016
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00753714
Brief Title
Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
Intervention Type
Drug
Intervention Name(s)
ZD6474, Vandetanib
Other Intervention Name(s)
Zactima
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
Intervention Type
Drug
Intervention Name(s)
Placebo to Match ZD6474, Vandetanib
Other Intervention Name(s)
Zactima
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
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
Oct 2008- dec 2011
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
Oct 2008- dec 2011
Title
Overall Objective Response
Time Frame
Oct 2008- dec 2011
Title
Duration of Response
Time Frame
Oct 2008- dec 2011
Title
The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine
Description
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
Time Frame
Oct 2008- Dec 2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Meldola
State/Province
(fc)
Country
Italy
Facility Name
Research Site
City
Avellino
State/Province
AV
Country
Italy
Facility Name
Research Site
City
Bari
State/Province
BA
Country
Italy
Facility Name
Research Site
City
Treviglio
State/Province
BG
Country
Italy
Facility Name
Research Site
City
Bologna
State/Province
BO
Country
Italy
Facility Name
Research Site
City
Genova
State/Province
GE
Country
Italy
Facility Name
Research Site
City
Taormina
State/Province
ME
Country
Italy
Facility Name
Research Site
City
Milano
State/Province
MI
Country
Italy
Facility Name
Research Site
City
Perugia
State/Province
PG
Country
Italy
Facility Name
Research Site
City
Ravenna
State/Province
RA
Country
Italy
Facility Name
Research Site
City
Trento
State/Province
TN
Country
Italy
Facility Name
Research Site
City
Orbassano
State/Province
TO
Country
Italy
Facility Name
Research Site
City
Udine
State/Province
UD
Country
Italy
Facility Name
Research Site
City
Padova
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18165633
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.
Results Reference
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Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine

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