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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00451906
First received: March 22, 2007
Last updated: March 23, 2016
Last verified: March 2016

March 22, 2007
March 23, 2016
August 2006
June 2009   (final data collection date for primary outcome measure)
  • Number of Participants With Adverse Events of Special Interest [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.
Safety: AEs, laboratory tests.
Complete list of historical versions of study NCT00451906 on ClinicalTrials.gov Archive Site
  • Duration of Overall Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Efficacy: Duration of survival; time to disease progression
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
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
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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Squamous Non-Small Cell Lung Cancer
  • Drug: Platinum-based chemotherapy
    As prescribed
  • Drug: Bevacizumab [Avastin]
    15 mg/kg IV on Day 1 of each 3 week cycle
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]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2252
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
Former Serbia and Montenegro,   Greece,   Jordan
 
NCT00451906
MO19390
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2016

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