A Phase I/II Study of PTK787 in Combination With Trastuzumab in Patients With Newly Diagnosed HER2 Overexpressing Locally Recurrent or Metastatic Breast Cancer: Hoosier Oncology Group Trial BRE04-80
OUTLINE: This is a multi-center study.
PTK787 daily plus trastuzumab 4 mg/kg IV week 1, followed by 2 mg/kg weekly with disease
evaluation every other cycle.
Patients may continue treatment until disease progression or toxicity intervenes.
Performance Status: ECOG 0 or 1
Life Expectancy: Not specified
Hematopoietic:
- ANC > 1500 mm3
- Platelets > 100,000 mm3
- Hemoglobin > 9 g/dL
- PTT and INR < 1.5 x ULN
Hepatic:
- ALT and AST < 3 x ULN (< 5 x ULN in patients with known liver metastases)
- Alkaline phosphatase < 2.5 x ULN
- Serum bilirubin < 1.5 x ULN
Renal:
- Serum creatinine < 1.5 x ULN
- Proteinuria < 1+ by dipstick OR total urinary protein < 500 mg/24 hours with measured
creatinine clearance (CrCl) ≥ 50 mL/min
Cardiovascular:
- No clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
coronary artery disease and cardiac arrhythmias not well controlled with medication) or
myocardial infarction within the last 6 months.
- LVEF > LLN by MUGA or ECHO (obtained within 28 days prior to being registered for
protocol therapy)
Pulmonary:
- Not specified
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I Cohorts:
18 months
Yes
Kathy Miller, M.D.
Study Chair
Hoosier Oncology Group, LLC
United States: Food and Drug Administration
HOG BRE04-80
NCT00216047
January 2005
August 2006
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Center for Cancer Care at Goshen Health System | Goshen, Indiana 46526 |
Arnett Cancer Care | Lafayette, Indiana 47904 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Elkhart Clinic | Elkhart, Indiana 46515 |
Medical Consultants, P.C. | Muncie, Indiana 47303 |
AP&S Clinic | Terre Haute, Indiana 47804 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |