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Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer (Excluding Squamous Cell)
This study is currently recruiting participants.
Verified by Stanford University, April 2009
First Received: May 8, 2006   Last Updated: April 3, 2009   History of Changes
Sponsors and Collaborators: Stanford University
Eli Lilly and Company
Genentech
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00323869
  Purpose

This is a phase II, open label, single arm, multi-institutional trial with a primary endpoint of improvement in progression-free survival (PFS) in newly diagnosed advanced non-small cell lung cancer (NSCLC) (excluding squamous cell carcinoma). All patients will be treated with bevacizumab (15 mg/kg every 3 weeks) in combination with gemcitabine (1000 mg/m2 on day 1 and 8 every 3 weeks) and carboplatin (AUC of 5 every 3 weeks). Patients will receive a maximum of 6 cycles of chemotherapy, but treatment with bevacizumab will continue as long as patients have no evidence of progressive disease and no significant treatment related toxicities.


Condition Intervention Phase
Lung Cancer
Drug: bevacizumab
Drug: gemcitabine
Procedure: chemotherapy
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Gemcitabine Gemcitabine hydrochloride Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: 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)

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Progression-free survival (PFS) in newly diagnosed advanced non-small cell lung cancer (NSCLC) (excluding squamous cell carcinoma)

Estimated Enrollment: 50
Study Start Date: June 2006
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Advanced stage NSCLC (IIIB with malignant pleural effusion or stage IV) 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 will be 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.
  • Life expectancy of at least 3 months.
  • ECOG Performance status 0-1.
  • Age 18 or higher.
  • Willingness to use appropriate contraception to avoid pregnancy during the study (female patient or female partner of a male patient)
  • Patients must have normal organ and marrow function as defined below:

    • 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 OR 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 (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 or 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 or coagulopathy.
  • Use of anti-coagulant agents including warfarin, heparin, aspirin, NSAIDs.
  • Pregnant (positive pregnancy test) or lactating women.
  • 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, fine needle aspirations or core biopsies within 7 days prior to day 0.
  • Urine protein:creatinine ratio >= 1.0 at screening.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, or with 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).
  • Significant co-morbidities including:

    • Blood pressure of >150/100 mmHg
    • Unstable angina
    • New York Heart Association (NYHA) Grade II 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323869

Contacts
Contact: Julia Dugay (650) 725-6413 jdugay@stanford.edu

Locations
United States, California
Santa Clara Valley Medical Center Recruiting
San Jose, California, United States
Contact: Natalia Kouzminova     408-793-1980     Natalia.Kouzminova@hhs.co.santa-clara.ca.us    
Principal Investigator: Gary Zhoa            
VA Palo Alto Healthcare System Recruiting
Palo Alto, California, United States
Contact: Julia Dugay     650-725-6413     jdugay@stanford.edu    
Principal Investigator: Kristen Ganjoo            
Stanford University School of Medicine Active, not recruiting
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Eli Lilly and Company
Genentech
Investigators
Principal Investigator: Gary Zhoa Santa Clara Valley Health & Hospital System
Principal Investigator: Heather A. Wakelee Stanford University
Principal Investigator: Kristen Ganjoo VA Palo Alto Healthcare System
  More Information

No publications provided

Responsible Party: Stanford University School of Medicine ( Heather A. Wakelee, Principal Investigator )
Study ID Numbers: LUN0013, 96655, AVF3576s, LUN0013, NCT00323869
Study First Received: May 8, 2006
Last Updated: April 3, 2009
ClinicalTrials.gov Identifier: NCT00323869     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Study placed in the following topic categories:
Antimetabolites
Thoracic Neoplasms
Immunologic Factors
Carboplatin
Bevacizumab
Squamous Cell Carcinoma
Angiogenesis Inhibitors
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Epidermoid Carcinoma
Non-small Cell Lung Cancer
Carcinoma, Squamous Cell
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Bevacizumab
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
Enzyme Inhibitors
Carboplatin
Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung

ClinicalTrials.gov processed this record on May 07, 2009