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Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00323869
Recruitment Status : Completed
First Posted : May 10, 2006
Results First Posted : July 27, 2016
Last Update Posted : September 7, 2016
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech, Inc.
Information provided by (Responsible Party):
Heather Wakelee, Stanford University

Tracking Information
First Submitted Date  ICMJE May 8, 2006
First Posted Date  ICMJE May 10, 2006
Results First Submitted Date  ICMJE April 20, 2016
Results First Posted Date  ICMJE July 27, 2016
Last Update Posted Date September 7, 2016
Study Start Date  ICMJE June 2006
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Progression-free Survival (PFS) [ Time Frame: 18 months ]
Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • Response Rate (CR + PR + SD) [ Time Frame: 6 weeks ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, by computed tomography (CT); bone scan; positron emission tomography (PET) scan; and/or magnetic resonance imaging (MRI) as necessary to assess diseasE Response determined as the number of subjects with any clinical response (CR + PR + SD) per RECIST criteria.
    • Complete Response (CR) = disappearance of all target lesions
    • Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions
    • Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, or appearance of new cancer lesions
    • Stable Disease (SD): No significant effect, does not meet criteria for PR or PD.
  • Overall Survival (OS) [ Time Frame: 36 months ]
    To evaluate the safety of the combination regimen.
  • Partial Response (PR) [ Time Frame: 6 weeks ]
    Number of subjects with PR per RECIST criteria
  • Complete Response (CR) [ Time Frame: 6 weeks ]
    Number of subjects with CR per RECIST criteria
  • Stable Disease (SD) [ Time Frame: 6 weeks ]
    Number of subjects with SD per RECIST criteria
  • Time-to-First Event [ Time Frame: 18 months ]
    Median time-to-first event, with events defined as disease progression, death, or toxicity requiring drug discontinuation
  • Overall Survival (OS) at 12 Months [ Time Frame: 12 months ]
    Number of subjects surviving 1 year after treatment initiation
  • Overall Survival (OS) at 24 Months [ Time Frame: 24 months ]
    Number of subjects surviving 2 years after treatment initiation
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer
Official Title  ICMJE Phase II Trial of Bevacizumab in Combination With Gemcitabine and Carboplatin in Patients With Newly Diagnosed Non-Small Cell Lung Cancer (Excluding Squamous Cell Carcinoma)
Brief Summary A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).
Detailed Description

This is a open-label, phase 2, single-arm, multi-center study of bevacizumab combined with gemcitabine and carboplatin. This treatment is for newly-diagnosed advanced non-small cell lung cancer (NSCLC), excluding squamous cell carcinoma. All subjects will receive 15 mg/kg bevacizumab every 3 weeks cycle, 1000 mg/m² of gemcitabine on day 1 and 8 every 3 weeks cycle and carboplatin (AUC= 5 ) every 3 weeks. Carboplasm will be administered 1 hour prior to the gemcitabine infusion, bevacizumab will be administered 1 hour following chemotherapy infusion.

Subjects will receive a maximum of 6 cycles of chemotherapy, but treatment with bevacizumab may continue as long as patients have no evidence of progressive disease and no significant treatment-related toxicities.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Non-small Cell Lung Cancer (NSCLC)
Intervention  ICMJE
  • Drug: Bevacizumab
    Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody
    Other Names:
    • Avastin
    • C225
    • rhuMAb-VEGF
  • Drug: Gemcitabine
    Nucleoside analog
    Other Name: Gemzar
  • Drug: Carboplatin
    Alkylating agent
    Other Names:
    • Paraplatin
    • CBDCA
Study Arms  ICMJE Experimental: Bevacizumab + carboplatin + gemcitabine

Bevacizumab in combination with carboplatin and gemcitabine:

•Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles.

Carboplatin was administered before the gemcitabine infusion:

•Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles

Bevacizumab was administered 1 hour after end of all chemotherapy infusions:

•Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity

Interventions:
  • Drug: Bevacizumab
  • Drug: Gemcitabine
  • Drug: Carboplatin
Publications * Clément-Duchêne C, Krupitskaya Y, Ganjoo K, Lavori P, McMillan A, Kumar A, Zhao G, Padda S, Zhou L, Pedro-Salcedo MS, Colevas AD, Wakelee HA. A phase II first-line study of gemcitabine, carboplatin, and bevacizumab in advanced stage nonsquamous non-small cell lung cancer. J Thorac Oncol. 2010 Nov;5(11):1821-5. doi: 10.1097/JTO.0b013e3181f1d23c.

*   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: June 14, 2016)
48
Original Enrollment  ICMJE
 (submitted: May 8, 2006)
50
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • Age 18 or higher
  • Life expectancy of at least 3 months
  • ECOG Performance status 0 to 1
  • Advanced stage non-small cell lung cancer, NSCLC, Stage IIIB with malignant pleural effusion or Stage 4, excluding squamous cell histology, with measurable or evaluable disease
  • No prior systemic therapy for advanced NSCLC (prior therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry)
  • Palliative radiotherapy to painful bony metastases is permitted prior to study entry if completed prior to initiation of study treatment, and there are no residual sequelae of therapy such as bone marrow suppression
  • Willingness to use appropriate contraception to avoid pregnancy during the study
  • Leukocytes ≥ 3,000/µL
  • Absolute neutrophil count ≥ 1,500/ µL
  • Platelets ≥ 100,000/ µL
  • Total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal
  • Creatinine: Within normal institutional limits
  • Creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal
  • Ability to sign informed consent

Exclusion Criteria:

  • Prior systemic treatment for advanced NSCLC (one prior regimen of up to 4 cycles of neoadjuvant or adjuvant therapy for early stage disease will be allowed, if completed at least 6 months prior to study entry)
  • Known brain metastases
  • Prior treatment with bevacizumab
  • History of allergic reactions
  • Sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study
  • Concomitant chemotherapy, radiotherapy, or investigational agents
  • Evidence of bleeding diathesis
  • Coagulopathy
  • Use of anti-coagulant agents including warfarin, heparin, aspirin, NSAIDs
  • Pregnant
  • Lactating
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
  • Minor surgical procedures within 7 days prior to day 0
  • Fine needle aspirations within 7 days prior to day 0
  • Core biopsies within 7 days prior to day 0
  • Urine protein: creatinine ratio ≥ 1.0 at screening
  • History of abdominal fistula within 6 months prior to Day 0
  • Gastrointestinal perforation within 6 months prior to Day 0
  • Intra-abdominal abscess within 6 months prior to Day 0
  • Serious, non-healing wound
  • Ulcer
  • Bone fracture
  • Lung carcinoma of squamous cell histology
  • Any histology in close proximity to a major vessel
  • Significant cavitation as assessed by treating investigator in consultation with an attending radiologist
  • History of hemoptysis (bright red blood of 1/2 teaspoon or more)
  • Blood pressure of > 150/100 mmHg
  • Unstable angina
  • New York Heart Association (NYHA) Grade 2 or greater congestive heart failure
  • History of myocardial infarction within 6 months
  • History of stroke within 6 months
  • Clinically significant peripheral vascular disease
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Another active malignancy except for non-melanoma skin cancers
  • Inability to comply with study and/or follow-up procedures
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00323869
Other Study ID Numbers  ICMJE IRB-03730
96655 ( Other Identifier: Stanford IRB alternate number )
AVF3576s
LUN0013 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Heather Wakelee, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE
  • Eli Lilly and Company
  • Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Heather A Wakelee, MD Stanford University
PRS Account Stanford University
Verification Date July 2016

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