Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer
Trial ID or NCT#
NCT00323869
Status
NOT RECRUITING
Purpose
A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).
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)
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Melanie San Pedro-Salcedo
6507241388
View on ClinicalTrials.gov