A Phase II Study of Erlotinib With Bevacizumab in Chemotherapy Naïve Performance Status (PS) 2 Patients With Advanced Non-Small Cell Lung Cancer
OUTLINE: This is a multi-center study.
- Bevacizumab 15 mg/kg IV on day 1
- Erlotinib 150 mg po qd days 1-21
- Disease Assessment during even numbered cycles
If no progressive disease observed, continue (combination or single agent- see below) until
unacceptable toxicity or progressive disease.
If progressive disease observed, treatment will be discontinued.
- Cycles will be repeated every 21 days up to a total of 6 cycles.
- Patients with non-progression after 6 cycles may stay on therapy (single agent
erlotinib or the combination) until progressive disease or intolerable toxicity (at the
- Patients who require discontinuation of bevacizumab may receive at investigator's
discretion erlotinib alone on study until progression.
- Patients who require discontinuation of erlotinib may receive at investigator's
discretion bevacizumab alone until progression.
ECOG Performance Status 2
- Absolute neutrophil count (ANC) > 1,000 mm3
- Platelet count > 100,000 mm3
- Hemoglobin > 8 g/dl
- Bilirubin < 2 X upper limit of normal.
- Aspartate aminotransferase (AST, SGOT) < 2.5 X upper limit of normal or 5 X if liver
- Urine protein:creatinine ratio 1.0 at screening
- Blood pressure of < 150/100 mmHg.
- No history of unstable angina.
- No history of New York Heart Association (NYHA) Grade II or greater congestive heart
- No history of myocardial infarction within 6 months prior to registration for protocol
- No history of stroke within 6 months prior to registration for protocol therapy.
- No clinically significant peripheral vascular disease.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To establish rate of non-progressive disease at 4 months in patients with advanced NSCLC who have been designated PS2 by their treating physician
Nasser Hanna, M.D.
Hoosier Oncology Group, LLC
United States: Institutional Review Board
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Methodist Cancer Center||Omaha, Nebraska 68114|
|Oncology Partners Network||Cincinnati, Ohio 45238|
|Arnett Cancer Care||Lafayette, Indiana 47904|
|Northern Indiana Cancer Research Consortium||South Bend, Indiana|
|Medical & Surgical Specialists, LLC||Galesburg, Illinois 61401|
|Cancer Care Center Of Southern Indiana||Bloomington, Indiana 47403|
|Horizon Oncology Center||Lafayette, Indiana 47905|
|Oncology Hematology Associates of SW Indiana||Evansville, Indiana 47714|
|Community Regional Cancer Center||Indianapolis, Indiana 46256|
|Quality Cancer Center (MCGOP)||Indianapolis, Indiana 46202|
|Medical Consultants, P.C.||Muncie, Indiana 47303|
|Fort Wayne Oncology & Hematology, Inc||Fort Wayne, Indiana 46815|