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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech
Information provided by (Responsible Party):
Heather Wakelee, Stanford University
ClinicalTrials.gov Identifier:
NCT00323869
First received: May 8, 2006
Last updated: October 25, 2013
Last verified: October 2013
  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
Drug: carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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) [ Time Frame: every six weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2006
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bevacizumab
bevacizumab in combination with carboplatin and gemcitabine
Drug: bevacizumab Drug: gemcitabine Drug: carboplatin

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323869

Locations
United States, California
VA Palo Alto Healthcare System
Palo Alto, California, United States
Santa Clara Valley Medical Center
San Jose, California, United States
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Eli Lilly and Company
Genentech
Investigators
Principal Investigator: Heather A. Wakelee Stanford University
  More Information

No publications provided

Responsible Party: Heather Wakelee, Stanford University
ClinicalTrials.gov Identifier: NCT00323869     History of Changes
Other Study ID Numbers: LUN0013, 96655, AVF3576s, LUN0013
Study First Received: May 8, 2006
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Gemcitabine
Bevacizumab
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014