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

Completed · Phase 2

Conditions studied: Lung Cancer, Non-small Cell Lung Cancer (NSCLC)

In brief

A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).

Key facts

Study ID

NCT00323869

Run by

Stanford University

People needed

48

Starts

2006-06-01

Expected to finish

2013-10-01

Last updated by the study team

2016-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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