PTK787 + Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoosier Cancer Research Network
• Collaborators: Novartis Pharmaceuticals; Walther Cancer Institute
• Treatments: Trastuzumab; Vatalanib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).