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: Yes
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
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