NCT00216047

PTK787 + Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	PTK787	PTK787 daily
DRUG	Trastuzumab	Trastuzumab 4 mg/kg IV week 1, followed by 2 mg/kg weekly with disease evaluation every other cycle\*

Timeline

• Start date: 2005-01-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2005-09-22
• Last updated: 2015-12-09

Locations

8 sites across 1 country: United States