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
- ANC > 1500 mm3
- Platelets > 100,000 mm3
- Hemoglobin > 9 g/dL
- PTT and INR < 1.5 x ULN
- 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
- 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
- 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
- Not specified
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I Cohorts:
Kathy Miller, M.D.
Hoosier Oncology Group, LLC
United States: Food and Drug Administration
|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|