Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216047
Status:
TERMINATED
Last Update Posted:
2015-12-09
First Post:
2005-09-12
Brief Title:
PTK787 Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer
Sponsor:
Hoosier Cancer Research Network
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase III 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
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low patient enrollment toxicities
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor its receptors may enhance the efficacy of trastuzumab monotherapy
This trial will investigate the safety and efficacy of combined HER2 and VEGF inhibition
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 mgkg IV week 1 followed by 2 mgkg 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 100000 mm3
Hemoglobin 9 gdL
PTT and INR 15 x ULN
Hepatic
ALT and AST 3 x ULN 5 x ULN in patients with known liver metastases
Alkaline phosphatase 25 x ULN
Serum bilirubin 15 x ULN
Renal
Serum creatinine 15 x ULN
Proteinuria 1 by dipstick OR total urinary protein 500 mg24 hours with measured creatinine clearance CrCl 50 mLmin
Cardiovascular
No clinically significant cardiac disease eg 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
PTK787 daily plus trastuzumab 4 mgkg IV week 1 followed by 2 mgkg 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 100000 mm3
Hemoglobin 9 gdL
PTT and INR 15 x ULN
Hepatic
ALT and AST 3 x ULN 5 x ULN in patients with known liver metastases
Alkaline phosphatase 25 x ULN
Serum bilirubin 15 x ULN
Renal
Serum creatinine 15 x ULN
Proteinuria 1 by dipstick OR total urinary protein 500 mg24 hours with measured creatinine clearance CrCl 50 mLmin
Cardiovascular
No clinically significant cardiac disease eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None