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
physician discretion).
- 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
Hematopoietic:
- Absolute neutrophil count (ANC) > 1,000 mm3
- Platelet count > 100,000 mm3
- Hemoglobin > 8 g/dl
Hepatic:
- Bilirubin < 2 X upper limit of normal.
- Aspartate aminotransferase (AST, SGOT) < 2.5 X upper limit of normal or 5 X if liver
involvement.
Renal:
- Urine protein:creatinine ratio 1.0 at screening
Cardiovascular:
- 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
failure.
- No history of myocardial infarction within 6 months prior to registration for protocol
therapy.
- No history of stroke within 6 months prior to registration for protocol therapy.
- No clinically significant peripheral vascular disease.
Interventional
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
4 months
No
Nasser Hanna, M.D.
Study Chair
Hoosier Oncology Group, LLC
United States: Institutional Review Board
HOG LUN04-77
NCT00367601
August 2006
December 2008
Name | Location |
---|---|
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 |