A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- To determine the activity of induction chemotherapy comprising carboplatin and
paclitaxel albumin-stabilized nanoparticle formulation followed by concurrent thoracic
radiotherapy and erlotinib hydrochloride in patients with poor-risk, unresectable stage
IIIA or IIIB non-small cell lung cancer.
Secondary
- To determine the response rate and progression-free survival of these patients.
OUTLINE: Patients receive induction chemotherapy comprising paclitaxel albumin-stabilized
nanoparticle formulation IV over 30 minutes on days 1 and 8 and carboplatin IV over 30
minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease
progression outside of the chest after induction therapy are removed from study. Patients
with intrathoracic disease progression within the potential radiation field may continue
protocol therapy at the discretion of the Study Chair. Patients with no disease progression
outside the planned radiation field (either regional or distant) proceed to concurrent
erlotinib hydrochloride and radiotherapy.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily.
Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions)
in the absence of rapid disease progression outside of the chest or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 1 year, and then
every 6 months for up to 2 years
Interventional
Masking: Open Label, Primary Purpose: Treatment
Overall survival at 12 months
No
Rogerio C. Lilenbaum, MD
Study Chair
Cleveland Clinic Florida - Weston
United States: Federal Government
CDR0000573832
NCT00553462
March 2008
Name | Location |
---|---|
National Naval Medical Center | Bethesda, Maryland 20889 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
CancerCare of Maine at Eastern Maine Medical Center | Bangor, Maine 04401 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Danville Regional Medical Center | Danville, Virginia 24541 |
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
Poudre Valley Radiation Oncology | Fort Collins, Colorado 80528 |
Highland General Hospital | Oakland, California 94602 |
Palo Alto Medical Foundation | Palo Alto, California 94301 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Saint Luke's Hospital - South | Overland Park, Kansas 66213 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
St. Joseph Medical Center | Kansas City, Missouri 64114 |
Heartland Hematology Oncology Associates, Incorporated | Kansas City, Missouri 64118 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Liberty Hospital | Liberty, Missouri 64068 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Saint Joseph Oncology, Incorporated | Saint Joseph, Missouri 64507 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton, Virginia 24273 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Elliot Regional Cancer Center at Elliot Hospital | Manchester, New Hampshire 03103 |
Rex Cancer Center at Rex Hospital | Raleigh, North Carolina 27607 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Harold Alfond Center for Cancer Care | Augusta, Maine 04330 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
Lakes Region General Hospital | Laconia, New Hampshire 03246 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
Boston University Cancer Research Center | Boston, Massachusetts 02118 |
Parvin Radiation Oncology | Kansas City, Missouri 64116 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
El Camino Hospital Cancer Center | Mountain View, California 94040 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
Tom K Lee, Incorporated | Oakland, California 94609 |
Bay Area Breast Surgeons, Incorporated | Oakland, California 94609 |
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord, New Hampshire 03301 |
New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
Valley Medical Oncology Consultants - Castro Valley | Castro Valley, California 94546 |
Valley Medical Oncology | Fremont, California 94538 |
Southeastern Regional Medical Center | Lumberton, North Carolina 28359 |
Granville Medical Center | Oxford, North Carolina 27565 |
Duke Health Raleigh Hospital | Raleigh, North Carolina 27609 |
Person Memorial Hospital | Roxboro, North Carolina 27573 |
Camino Medical Group - Treatment Center | Mountain View, California 94040 |
CCOP - Kansas City | Prairie Village, Kansas 66208 |