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A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

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ClinicalTrials.gov Identifier: NCT00451906
Recruitment Status : Completed
First Posted : March 26, 2007
Results First Posted : April 25, 2016
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 22, 2007
First Posted Date  ICMJE March 26, 2007
Results First Submitted Date  ICMJE March 23, 2016
Results First Posted Date  ICMJE April 25, 2016
Last Update Posted Date May 24, 2016
Study Start Date  ICMJE August 2006
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • Number of Participants With Adverse Events of Special Interest [ Time Frame: Up to 3 years ]
    Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.
  • Number of Participants With Serious Adverse Events Related to Bevacizumab [ Time Frame: Up to 3 years ]
    Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2007)
Safety: AEs, laboratory tests.
Change History Complete list of historical versions of study NCT00451906 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • Duration of Overall Survival [ Time Frame: Up to 3 years ]
    Overall survival time was defined as time between first bevacizumab administration and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive.
  • Time to Disease Progression [ Time Frame: Up to 3 years ]
    Time to disease progression was defined as time between first bevacizumab administration and date of first occurrence of progressive disease. Participants who had not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.
  • Number of Participants With Central Nervous System Bleeding [ Time Frame: Up to 3 years ]
    The incidence of central nervous system (CNS) bleeding was reported for participants who developed CNS metastases during the study period and who did not have Computed Tomography (CT) or magnetic resonance imaging (MRI) techniques of the head performed at baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2007)
Efficacy: Duration of survival; time to disease progression
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Official Title  ICMJE Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
Brief Summary This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Squamous Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Platinum-based chemotherapy
    As prescribed
  • Drug: Bevacizumab [Avastin]
    15 mg/kg IV on Day 1 of each 3 week cycle
Study Arms  ICMJE Experimental: Bevacizumab + Chemotherapy
Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.
Interventions:
  • Drug: Platinum-based chemotherapy
  • Drug: Bevacizumab [Avastin]
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2016)
2252
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
  • ECOG PS status 0-2;
  • life expectancy >= 12weeks;
  • adequate renal, liver and hematological function.

Exclusion Criteria:

  • mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
  • hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
  • evidence of tumor invading major blood vessels on imaging;
  • evidence of CNS metastases, even if previously treated.
  • major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
  • prior chemotherapy for stage IIIb/IV disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Bosnia and Herzegovina,   Brazil,   Canada,   China,   Colombia,   Czech Republic,   Denmark,   Ecuador,   Egypt,   Estonia,   Finland,   France,   Germany,   Hong Kong,   Hungary,   Iceland,   Israel,   Italy,   Latvia,   Lebanon,   Lithuania,   Mexico,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   Venezuela
Removed Location Countries Former Serbia and Montenegro,   Greece,   Jordan
 
Administrative Information
NCT Number  ICMJE NCT00451906
Other Study ID Numbers  ICMJE MO19390
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP