A Phase II Trial of Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer
Eligible patients will receive a minimum of six cycles of combination therapy. If a patient
is still responding to the oxaliplatin at 6 cycles, the oxaliplatin may be continued with
the trastuzumab up to 10 cycles at the investigator's discretion. After discontinuing the
oxaliplatin/trastuzumab combination, patients should continue with single agent trastuzumab
until disease progression.
Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion
over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV
dose over 30 minutes. Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120
minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day
cycles.
For the first cycle, trastuzumab will be administered before oxaliplatin; however for
subsequent cycles, oxaliplatin will be infused prior to trastuzumab
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
18 months
No
Denise A. Yardley, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI BRE 77
NCT00297596
February 2006
October 2010
Name | Location |
---|---|
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Baton Rouge General Medical Center | Baton Rouge, Louisiana 70821-2511 |
Chattanooga Oncology and Hematology Associates | Chattanooga, Tennessee 37404 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Hematology Oncology Life Center | Alexandria, Louisiana 71301 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Graves-Gilbert Clinic | Bowling Green, Kentucky 42101 |