Salvage Therapy With Bevacizumab Plus Docetaxel and Cisplatin for Taiwanese Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Bevacizumab is a monoclonal antibody currently used for the treatment of colorectal cancer. It works by preventing the formation of new blood vessels (angiogenesis). The drug has been shown to inhibit vascular endothelial growth factor (VEGF) activity. Previous research showed positive findings in other solid tumors that had metastasized. In this study, the investigators are investigating the response of adding bevacizumab to conventional chemotherapy for metastatic breast cancer patients.

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

Details

• Lead Sponsor: Taipei Medical University Hospital
• Treatments: Bevacizumab; Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.

• Normal left ventricular ejection fraction (LVEF).

• Age ≤ 65 years.

• At least one unidimensionally measurable lesion by imaging studies.

• AST/ALT 2.5 ULN (< 5 ULN if liver metastases).

• Serum bilirubin 3 ULN, Serum Creatinine 1.5 ULN.

• Urine dipstick of proteinuria <2+.

• Women of childbearing potential must have a negative serum pregnancy test.

Exclusion Criteria:

• Uncontrolled hypertension (systolic blood pressure > 160 mm Hg, diastolic blood pressure > 90 mm Hg).

• Prior exposure to bevacizumab.

• Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed), except bone metastasis.

• Evidence of bleeding diathesis or coagulopathy.

• Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. Stroke in the preceding six months.

• Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of bevacizumab with chemotherapy.

• Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration.

• Pregnancy (positive serum pregnancy test) and lactation. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.