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Brief Title: PTK787 + Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer
Official Title: 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
Study ID: NCT00216047
Brief Summary: HER2 gene amplification increases VEGF production in breast cancers; combined inhibition of HER2 and VEGF enhances response in xenograft models. The upregulation of VEGF in HER2-overexpressing breast cancers may contribute to the aggressive phenotype observed in HER2-positive breast cancer. New therapeutics targeting VEGF and/or its receptors may enhance the efficacy of trastuzumab monotherapy. This trial will investigate the safety and efficacy of combined HER2 and VEGF inhibition.
Detailed Description: 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Elkhart Clinic, Elkhart, Indiana, United States
Fort Wayne Oncology & Hematology, Inc, Fort Wayne, Indiana, United States
Center for Cancer Care at Goshen Health System, Goshen, Indiana, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Arnett Cancer Care, Lafayette, Indiana, United States
Medical Consultants, P.C., Muncie, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
AP&S Clinic, Terre Haute, Indiana, United States
Name: Kathy Miller, M.D.
Affiliation: Hoosier Oncology Group, LLC
Role: STUDY_CHAIR