Status:
COMPLETED
Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Genentech, Inc.
Celgene Corporation
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
OBJECTIVES: Primary * To determine the progression-free survival of patients with locally recurrent or metastatic breast cancer treated with carboplatin, paclitaxel albumin-stabilized nanoparticle f...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed primary adenocarcinoma of the breast
- Locally recurrent or metastatic disease
- Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to receive trastuzumab (Herceptin®) or have previously received trastuzumab in the past
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm by conventional techniques or as \> 10 mm by spiral CT scan.
- No known CNS disease
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
- Prior neoadjuvant or adjuvant chemotherapy allowed
- More than 1 week since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device
- More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy
- More than 4 weeks since prior radiotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- At least 1 year since prior taxane regimen
- No other concurrent investigational agents
- Concurrent anticoagulation allowed, provided the following criteria are met:
- Stable dose of warfarin or low molecular weight heparin
- INR within desired range (2-3)
- No evidence of active bleeding or coagulopathy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent radiotherapy, chemotherapy, immunotherapy, or antitumor hormonal therapy
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00654836
Start Date
October 1 2007
End Date
September 1 2015
Last Update
September 14 2017
Active Locations (6)
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1
Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States, 60515-1500
2
Delnor Community Hospital - Geneva
Geneva, Illinois, United States, 60134-4200
3
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
4
Edward Hospital Cancer Center
Naperville, Illinois, United States, 60540