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

• ClinicalTrials.gov Identifier: NCT00753714
• Recruitment Status: Completed
• First Posted: September 16, 2008
• Results First Posted: September 28, 2012
• Last Update Posted: October 17, 2016
• Sponsor: Genzyme, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Genzyme, a Sanofi Company )

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.

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer	Drug: ZD6474, Vandetanib; Drug: Placebo to Match ZD6474, Vandetanib; Drug: Gemcitabine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: October 2008
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; 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.	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; Other Name: Zactima; Drug: 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; Other Name: Gemzar
Placebo Comparator: B; 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.	Drug: 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; Other Name: Zactima; Drug: 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; Other Name: Gemzar

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival [ Time Frame: Oct 2008- dec 2011 ]

Secondary Outcome Measures :

1. Overall Survival [ Time Frame: Oct 2008- dec 2011 ]
2. Overall Objective Response [ Time Frame: Oct 2008- dec 2011 ]
3. Duration of Response [ Time Frame: Oct 2008- dec 2011 ]
4. The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine [ Time Frame: Oct 2008- Dec 2011 ]
   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

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

Research Site

Meldola, (fc), Italy

Research Site

Avellino, AV, Italy

Research Site

Bari, BA, Italy

Research Site

Treviglio, BG, Italy

Research Site

Bologna, BO, Italy

Research Site

Genova, GE, Italy

Research Site

Taormina, ME, Italy

Research Site

Milano, MI, Italy

Research Site

Perugia, PG, Italy

Research Site

Ravenna, RA, Italy

Research Site

Trento, TN, Italy

Research Site

Orbassano, TO, Italy

Research Site

Udine, UD, Italy

Research Site

Padova, Italy

Research Site

Roma, Italy

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

Publications:

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.

• Responsible Party: Genzyme, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00753714
• Other Study ID Numbers: D4200L00012; EUDRACT n° 2007-004521-22
• First Posted: September 16, 2008
• Results First Posted: September 28, 2012
• Last Update Posted: October 17, 2016
• Last Verified: August 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):

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

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Gemcitabine; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs