Randomized Phase II Study of Pre-operative Chemoradiotherapy +/- Panitumumab (IND #110152) Followed by Consolidation Chemotherapy +/- Cetuximab in Potentially Operable Locally Advanced (Stage IIIA, N2+) Non-Small Cell Lung Cancer (Cetuximab Closed as of 05/14/10)
- Determine the mediastinal nodal clearance after completion of induction
chemoradiotherapy with or without panitumumab in patients with stage IIIA non-small
cell lung cancer. (cetuximab closed as of 05/14/10)
- Assess overall survival of these patients.
- Evaluate patterns of first failure in these patients.
- Determine the acute and late adverse events associated with these regimens.
- Assess surgical morbidities in patients with resectable disease at reassessment.
- Determine the correlation between pre- and post-treatment biomarkers (including
epidermal growth factor receptor (EGFR) and ras mutation status) and outcomes
(mediastinal nodal clearance and overall survival).
- Evaluate the prognostic value of plasma osteopontin and microRNA for overall survival.
- Assess the ability of FDG-PET/CT scan re-staging to predict outcome.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive induction therapy comprising paclitaxel IV over 1 hour and
carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo
intensity-modulated radiotherapy (IMRT) or 3-dimensional conformal radiotherapy
(3D-CRT) once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning
approximately 6-12 weeks later, patients receive consolidation therapy comprising
paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21.
- Arm II: Patients receive induction therapy comprising panitumumab IV over 1 hour on
days 1, 8, 15, 22, 29, and 36 and paclitaxel IV over 1 hour and carboplatin IV over 30
minutes on days 8, 15, 22, 29, and 36. Patients also undergo IMRT or 3D-CRT once daily
on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Beginning approximately 6-12 weeks
later, patients receive consolidation therapy comprising paclitaxel IV over 1 hour and
carboplatin IV over 30 minutes on days 1 and 21. (cetuximab closed as of 05/14/10) In
both arms, patients with resectable disease and no disease progression may proceed to
surgery (thoracotomy, lobectomy, or pneumonectomy) approximately 4-6 weeks after
completion of induction therapy. After surgery, patients proceed to consolidation
After completion of study treatment, patients are followed up at 6 weeks, every 3 months for
1 year, every 6 months for 2 years, and then annually thereafter.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Mediastinal nodal clearance after completion of induction chemoradiotherapy with or without panitumumab.
At the time of protocol surgery.
Martin J. Edelman, MD
University of Maryland Greenebaum Cancer Center
United States: Food and Drug Administration
|Penrose Cancer Center at Penrose Hospital||Colorado Springs, Colorado 80933|
|Fairview Southdale Hospital||Edina, Minnesota 55435|
|Virginia Piper Cancer Institute at Abbott - Northwestern Hospital||Minneapolis, Minnesota 55407|
|Natalie Warren Bryant Cancer Center at St. Francis Hospital||Tulsa, Oklahoma 74136|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|CCOP - Ochsner||New Orleans, Louisiana 70121|
|Albert Einstein Cancer Center||Philadelphia, Pennsylvania 19141|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|NYU Cancer Institute at New York University Medical Center||New York, New York 10016|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|Lucille P. Markey Cancer Center at University of Kentucky||Lexington, Kentucky 40536-0093|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Methodist Estabrook Cancer Center||Omaha, Nebraska 68114-4199|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|Bryn Mawr Hospital||Bryn Mawr, Pennsylvania 19010|
|Lankenau Cancer Center at Lankenau Hospital||Wynnewood, Pennsylvania 19096|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|
|York Cancer Center at Apple Hill Medical Center||York, Pennsylvania 17405|
|Radiological Associates of Sacramento Medical Group, Incorporated||Sacramento, California 95815|
|Boston University Cancer Research Center||Boston, Massachusetts 02118|
|Cancer Center of Paoli Memorial Hospital||Paoli, Pennsylvania 19301-1792|
|Veterans Affairs Medical Center - Milwaukee||Milwaukee, Wisconsin 53295|
|Cancer Institute at St. Joseph Medical Center||Towson, Maryland 21204|
|Mercy Cancer Center at Mercy San Juan Medical Center||Carmichael, California 95608|
|St. Agnes Hospital Cancer Center||Baltimore, Maryland 21229|
|Adams Cancer Center||Gettysburg, Pennsylvania 17325|
|Cherry Tree Cancer Center||Hanover, Pennsylvania 17331|