Phase II Pilot Trial of Carboplatin, Paclitaxel, and Herceptin in HER2/Neu (+) Advanced NSCLC
OBJECTIVES: I. Assess the toxicity of monoclonal antibody HER2 with carboplatin and
paclitaxel in patients with HER2 positive non-small cell lung cancer. II. Determine median
time to progression and one year freedom from progression in this patient population. III.
Evaluate one year survival rate and overall objective response rate in this patient
population.
OUTLINE: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV
over 30 minutes immediately followed by monoclonal antibody HER2 IV over 30-90 minutes on
day 1. Patients also receive monoclonal antibody HER2 on days 8 and 15. Treatment is
repeated every 3 weeks for 6 courses. After 6 courses of treatment, patients may receive
monoclonal antibody HER2 weekly for up to 1 year in the absence of disease progression or
unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for
3 years and once a year thereafter until disease progression or death.
PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Corey J. Langer, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000067048
NCT00003881
May 1999
July 2004
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Kaplan Cancer Center | New York, New York 10016 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
CCOP - Columbus | Columbus, Ohio 43206 |
Allegheny University Hospitals- Hahnemann | Philadelphia, Pennsylvania 19102-1192 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Evanston | Evanston, Illinois 60201 |
Veterans Affairs Medical Center - New York | New York, New York 10010 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - Pittsburgh | Pittsburgh, Pennsylvania 15240 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
Veterans Affairs Medical Center - Cleveland | Cleveland, Ohio 44106 |
Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |
Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Veterans Affairs Medical Center - Gainsville | Gainesville, Florida 32608-1197 |