Non Small Cell Lung Cancer Clinical Trial
— ZELIGOfficial 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.
Verified date | January 2013 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Italy,
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
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 |
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