AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer


Tracking Information

Start Date  ICMJEJuly 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2009)		Progression-free survival [ Time Frame: tumour assessment before cycle 3, at 2nd cycle of maintenance therapy and every 9 weeks thereafter ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00961415 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: August 18, 2009)
  • Response rate, disease control rate,duration of response, overall survival [ Time Frame: tumour assessment before cycle 3, at 2nd cycle of maintenance therapy and every 9 weeks thereafter ] [ Designated as safety issue: No ]
  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: throughout study, laboratory assessments every 3 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: EORTC-QLQ assessments every 2 cycles ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEAVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer
Official Title  ICMJEOpen-label Study of Bevacizumab Maintenance Therapy (AVASTIN®) With or Without Pemetrexed After First-line Chemotherapy With Bevacizumab-cisplatin-pemetrexed in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (NSCLC)
Brief Summary

This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is <500 individuals.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJENon-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: bevacizumab [AVASTIN]
    7.5mg/kg iv on day 1 of each 3-week cycle
  • Drug: pemetrexed
    500mg/m2 iv on day 1 of each 3-week cycle
  • Drug: cisplatin
    75mg/kg iv on day 1 of each 3-week cycle
Study Arms / Comparison Groups
  • Part 1: Experimental
    Interventions:
    • Drug: bevacizumab [AVASTIN]
    • Drug: pemetrexed
    • Drug: cisplatin
  • Part 2A: Experimental
    Intervention: Drug: bevacizumab [AVASTIN]
  • Part 2B: Active Comparator
    Interventions:
    • Drug: bevacizumab [AVASTIN]
    • Drug: pemetrexed

Recruitment Information

Estimated Enrollment  ICMJE362
Estimated Completion DateDecember 2011
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adults >/=18 years of age
  • inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC
  • at least 1 measurable lesion meeting RECIST criteria
  • ECOG performance status 0-2
  • adequate hematological, liver and renal function

Exclusion Criteria:

  • prior chemotherapy or treatment with another systemic anti-cancer agent
  • malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
  • evidence of tumour invading major blood vessels
  • current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
  • history of haemoptysis >/=grade 2
  • clinically significant cardiovascular disease
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: MO22089888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEFrance,   Germany,   Greece,   Italy,   Kuwait,   Netherlands,   Russian Federation,   Spain,   Sweden,   Switzerland,   Turkey,   United Arab Emirates

Administrative Information

NCT ID  ICMJENCT00961415
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEMO22089, 2008-007008-27
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche