Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with locally recurrent or metastatic breast cancer.

Key facts

Study ID

NCT00654836

Run by

Loyola University

People needed

32

Starts

2007-10-01

Expected to finish

2015-09-01

Last updated by the study team

2017-09-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Postmenopausal status not specified
• ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
• Life expectancy > 12 weeks
• WBC ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Total bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)
• Creatinine ≤ 1.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other concurrent malignancies within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

You may not qualify if…

• Pre-existing neuropathy ≥ grade 1
• Uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Serious, non-healing wound, ulcer, or bone fracture
• Psychiatric illness/social situations that would limit compliance with study requirements
• Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications)
• History of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association class II-IV congestive heart failure
• History of myocardial infarction or unstable angina within the past 6 months
• History of stroke or transient ischemic attack within the past 6 months
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• Symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Significant traumatic injury within the past 28 days
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• Proteinuria, as demonstrated by either urine protein:creatinine ratio ≥ 1.0 OR urine dipstick for proteinuria ≥ 2+
• Patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline must demonstrate 24-hour urine protein ≤ 1g
• History of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle formulation, paclitaxel, bevacizumab, carboplatin, albumin, drug product excipients, or chemically similar agents
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Recovered from all prior therapy
• No prior chemotherapy for locally recurrent or metastatic disease

Where it is running

• Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital — Downers Grove, Illinois, United States
• Delnor Community Hospital - Geneva — Geneva, Illinois, United States
• Cardinal Bernardin Cancer Center at Loyola University Medical Center — Maywood, Illinois, United States
• Edward Hospital Cancer Center — Naperville, Illinois, United States
• Swedish-American Regional Cancer Center — Rockford, Illinois, United States
• Central Dupage Cancer Center — Winfield, Illinois, United States

Full record on ClinicalTrials.gov

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