Status:
TERMINATED
PTK787 + Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Novartis Pharmaceuticals
Walther Cancer Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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 ...
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 di...
Eligibility Criteria
Inclusion
- Histologic or cytologic diagnosis of breast cancer with evidence of measurable (1) unresectable, locally recurrent, or (2) metastatic disease. Locally recurrent disease must not be amenable to resection OR radiation with curative intent.
- Patient's disease may not involve more than 3 metastatic sites. In addition, patient may not be symptomatic from pulmonary metastasis or have liver metastasis involving \> 50% of parenchyma.
- HER2 gene amplification by FISH. HER protein overexpression by immunohistochemistry will not be sufficient for entry.
- Negative pregnancy test
Exclusion
- No prior cytotoxic chemotherapy or trastuzumab for locally recurrent or metastatic disease.
- No prior treatment with any VEGF inhibiting agents
- No history or presence of central nervous system (CNS) disease.
- No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to being registered for protocol therapy.
- No major surgery within 28 days prior to being registered for protocol therapy.
- No uncontrolled hypertension (SBP \> 170, DBP \> 90), history of labile hypertension or history of poor compliance with antihypertensive therapy.
- No requirement for therapeutic anticoagulation, regular aspirin (\> 325 mg/day) or NSAID use.
- No current breast feeding.
- No impairment of gastrointestinal (GI) function that may significantly alter the absorption of PTK787.
- No evidence of other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00216047
Start Date
January 1 2005
End Date
August 1 2006
Last Update
December 9 2015
Active Locations (8)
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1
Elkhart Clinic
Elkhart, Indiana, United States, 46515
2
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
3
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
4
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202