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A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800202
First received: December 1, 2008
Last updated: November 10, 2014
Last verified: November 2014

December 1, 2008
November 10, 2014
April 2009
October 2012   (final data collection date for primary outcome measure)
  • Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Tumor progression was defined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm.
  • Percentage of Participants With Disease Progression or Death [ Time Frame: Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant ] [ Designated as safety issue: No ]
    Tumor progression was defined according to the RECIST criteria as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm.
  • Time to Disease Progression or Death [ Time Frame: Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant ] [ Designated as safety issue: No ]
    Tumor progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. Time to event was determined as the number of months between the first dose of study treatment and the first event of progression or death by any cause. PFS was analyzed using the Kaplan-Meier method in each treatment arm.
Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00800202 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Who Died [ Time Frame: Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death ] [ Designated as safety issue: No ]
  • Probability of Being Alive at 12 and 18 Months [ Time Frame: Months 12 and 18 ] [ Designated as safety issue: No ]
  • Time to Death [ Time Frame: Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death ] [ Designated as safety issue: No ]
    Time to death was determined as the number of months between the first dose of study treatment and the event of death by any cause. Overall survival was analyzed using the Kaplan-Meier method.
  • Percentage of Participants Achieving a Best Overall Response of Complete Response or Partial Response as Assessed by the Investigator Using RECIST [ Time Frame: Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant ] [ Designated as safety issue: No ]
    Overall response defined as best response according to RECIST recorded from date of randomization until disease progression or recurrence. Complete Response (CR): disappearance of all target lesions; Partial response (PR): reduction by at least 30 percent (%) of sum of the longest diameters of each target lesion, taking initial sum of longest diameters as a reference. Participants with a missing response were considered non-responders. 95% CI for one sample binomial using Pearson-Clopper method.
Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis
An Open Label Study to Assess the Effect of Avastin (Bevacizumab) Combined With First Line Paclitaxel-carboplatin or Second Line Tarceva (Erlotinib) on Progression-free Survival in Non-squamous Non-small Cell Lung Cancer Patients With Asymptomatic Untreated Brain Metastasis

This study will assess the efficacy and safety of Avastin combined with first li ne paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is until disease prog ression, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: bevacizumab [Avastin]
    15mg/kg iv every 3 weeks
  • Drug: carboplatin
    AUC6 iv every 3 weeks for 6 cycles
  • Drug: erlotinib [Tarceva]
    150mg/day po
  • Drug: paclitaxel
    200mg/m2 iv every 3 weeks for 6 cycles
  • Experimental: 1
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: 2
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: erlotinib [Tarceva]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • stage IV non-squamous non-small cell lung cancer;
  • asymptomatic, untreated brain metastasis;
  • ECOG performance status 0-1.

Exclusion Criteria:

  • previous treatment for brain metastasis;
  • history of migraine or epilepsy;
  • previous treatment with angiogenesis inhibitors;
  • for cohort 2, previous first line treatment with Avastin or Tarceva;
  • current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agent for therapeutic purposes.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00800202
ML21823, 2008-006504-33
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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