Lung Cancer Trials Ask AI to find trials
CompletedPhase 2NCT00323869
Official study title

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

Study 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).

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBevacizumab and Gemcitabine

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 7, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Stanford University

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Stanford University
Interventions being studied
Drug: Bevacizumab; Drug: Gemcitabine; Drug: Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • VA Palo Alto Healthcare SystemPalo Alto, California
  • Santa Clara Valley Medical CenterSan Jose, California
  • Stanford University School of MedicineStanford, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 7, 2016. Always confirm current availability with the study team.

View original record ↗