A Randomized Phase II Study of Radiation Therapy, Pemetrexed and Carboplatin With or Without Cetuximab in Stage III Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- Determine the overall survival of patients with unresectable stage III non-small cell
lung cancer treated with pemetrexed disodium, carboplatin, and thoracic radiotherapy
with or without cetuximab.
Secondary
- Determine the failure-free survival and response rates in patients treated with these
regimens.
- Correlate epidermal growth factor receptor, erbB2, and K-ras mutations with survival
and tumor response in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study.
- Chemoradiotherapy (courses 1-4): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive pemetrexed disodium IV over 10 minutes followed by
carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo
thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40,
and 43-47.
- Arm II: Patients receive pemetrexed disodium, carboplatin, and thoracic
radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1
and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
- Consolidation chemotherapy (courses 5-8): Beginning 3-5 weeks after completion of
chemoradiotherapy, all patients receive consolidation chemotherapy comprising
pemetrexed disodium alone IV over 10 minutes on day 1. Treatment repeats every 21 days
for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study within 10-13 months.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
18 Month Survival
Percentage of participants who were alive at 18 months. The 18 month survival, with 95% CI, was estimated using the Kaplan-Meier method.
18 months (from randomization)
No
Ramaswamy Govindan, MD
Study Chair
Washington University Siteman Cancer Center
United States: Food and Drug Administration
CDR0000434616
NCT00117962
September 2005
September 2012
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Mount Sinai Medical Center | New York, New York 10029 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Sibley Memorial Hospital | Washington, District of Columbia 20016 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Eden Medical Center | Castro Valley, California 94546 |
Saint Rose Hospital | Hayward, California 94545 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Valley Care Medical Center | Pleasanton, California 94588 |
Fort Wayne Medical Oncology and Hematology | Fort Wayne, Indiana 46815 |
St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Grand Island, Nebraska 68803 |
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 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Mountainview Medical | Berlin, Vermont 05602 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Highland General Hospital | Oakland, California 94602 |
Saint Luke's Hospital | Chesterfield, Missouri 63017 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis, Missouri 63141 |
Cancer Care Associates - Mercy Campus | Oklahoma City, Oklahoma 73120 |
Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton, Virginia 24273 |
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
Elliot Regional Cancer Center at Elliot Hospital | Manchester, New Hampshire 03103 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
Miriam Hospital | Providence, Rhode Island 02906 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
La Grange Memorial Hospital | La Grange, Illinois 60525 |
Lakes Region General Hospital | Laconia, New Hampshire 03246 |
Roper St. Francis Cancer Center at Roper Hospital | Charleston, South Carolina 29401 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
Iowa Blood and Cancer Care | Cedar Rapids, Iowa 52402 |
New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
Arroyo Grande Community Hospital | Arroyo Grande, California 93420 |
St. Anthony's Cancer Center | St. Louis, Missouri 63128 |
St. Mary's Regional Cancer Center at St. Mary's Medical Center | Huntington, West Virginia 25702 |
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis | St Louis, Missouri 63110 |
Callahan Cancer Center at Great Plains Regional Medical Center | North Platte, Nebraska 69103 |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115 |
Bendheim Cancer Center at Greenwich Hospital | Greenwich, Connecticut 06830 |
Upper Chesapeake Medical Center | Bel Air, Maryland 21014 |