A Phase II Study of OSI-774 (Tarceva) and Gemcitabine for Patients With Metastatic Breast Cancer
- Determine the anti-tumor activity of erlotinib and gemcitabine in patients with
metastatic breast cancer previously treated with anthracycline and/or taxane.
- Determine the adverse event profile of this regimen in these patients.
- Determine whether epidermal growth factor receptor and HER-2 receptor intensity and
serum concentrations have an impact on clinical response in patients treated with this
- Determine the impact of genetic differences in proteins involved in drug response
(transport, metabolism, and mechanism of action) on clinical response and adverse
events associated with gemcitabine in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV on days 1 and 8 and oral erlotinib on days 1-21. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response are followed every 6 weeks for up to 5 years or until
disease progression (PD). Patients discontinuing study therapy for any other reason are
followed every 3 months until PD and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 5-56 patients will be accrued for this study within 20 months.
Masking: Open Label, Primary Purpose: Treatment
Edith A. Perez, MD
United States: Federal Government
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Duluth||Duluth, Minnesota 55805|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|CCOP - Ochsner||New Orleans, Louisiana 70121|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Dayton||Kettering, Ohio 45429|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|CCOP - Oklahoma||Tulsa, Oklahoma 74136|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|CentraCare Health Plaza||Saint Cloud, Minnesota 56303|
|CCOP - Mayo Clinic Scottsdale Oncology Program||Scottsdale, Arizona 85259|