Erlotinib + Bevacizumab for PS 2 Chemotherapy Naïve Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria: Histological proof of non-small cell lung cancer meeting one of the following criteria: stage III b with a pleural effusion stage IV Histology must not be squamous cell. No prior chemotherapy or hormonal therapy. Prior radiation therapy must be completed at least 21 days prior to being registered for protocol therapy. No prior use of an epidermal growth factor receptor (EGFR) inhibitor or antiangiogenic agent. No treatment with any investigational agent within 30 days prior to being registered for protocol therapy. Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy. ECOG Performance Status of 2 in the opinion of the treating investigator. Age > 18 years at the time of consent. Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for a 6 week period thereafter. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Females must not be breastfeeding. Able to comply with study and/or follow-up procedures. Exclusion Criteria: Evidence of bleeding diathesis or coagulopathy. Evidence of central nervous system involvement or brain metastases confirmed by head CT or brain MRI within 28 days prior to being registered for protocol therapy. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy. Anticipation of need for major surgical procedure during the course of the study. Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for protocol therapy. Serious, non-healing wound, ulcer, or bone fracture. History of hemoptysis. Clinically significant infections as judged by the treating investigator. Other active malignancy
Sites / Locations
- Medical & Surgical Specialists, LLC
- Cancer Care Center of Southern Indiana
- Oncology Hematology Associates of SW Indiana
- Fort Wayne Oncology & Hematology, Inc
- Indiana University Cancer Center
- Quality Cancer Center (MCGOP)
- Community Regional Cancer Center
- Arnett Cancer Care
- Horizon Oncology Center
- Medical Consultants, P.C.
- Northern Indiana Cancer Research Consortium
- Methodist Cancer Center
- Oncology Partners Network
Arms of the Study
Arm 1
Experimental
1
Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.