Status:
UNKNOWN
ABI-007 and Bevacizumab in Treating Women With Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Premiere Oncology
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, suc...
Detailed Description
OBJECTIVES: Primary * Determine the activity of paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane\^®) and bevacizumab, in terms of progression-free survival and response rate...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed invasive breast cancer
- Recurrent or metastatic disease OR locally recurrent disease not amenable to resection with curative intent
- Measurable or nonmeasurable disease
- No CNS metastases by CT scan or MRI
- No HER2-neu-positive tumors
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Performance status 0-1
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count \> 100,000/mm³
- Creatinine \< 2.0 mg/dL
- Bilirubin normal
- AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if there is known liver involvement)
- Urine protein:creatinine ratio \< 1.0 OR proteinuria \< 2+ by urine dipstick OR ≤ 1 g protein on 24-hour urine collection
- No peripheral neuropathy \> grade 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancies within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell carcinoma of the skin
- No inadequately controlled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg and/or diastolic BP \> 100 mm Hg on antihypertensive medications
- No prior hypertensive crisis or hypertensive encephalopathy
- No New York Heart Association class II-IV congestive heart failure
- No myocardial infarction or unstable angina within the past 6 months
- No stroke or transient ischemic attack within the past 6 months
- No significant vascular disease (e.g., aortic aneurysm or aortic dissection)
- No symptomatic peripheral vascular disease
- No evidence of bleeding diathesis or coagulopathy
- No significant traumatic injury within the past 28 days
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No serious, nonhealing wound, ulcer, or bone fracture
- No known hypersensitivity to any component of bevacizumab
- PRIOR CONCURRENT THERAPY:
- No prior paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane\^®) or bevacizumab
- No prior chemotherapy for metastatic disease
- Prior hormonal therapy for metastatic disease allowed
- At least 4 weeks since any prior therapy for cancer
- More than 12 months since prior adjuvant chemotherapy, including use of a taxane
- More than 28 days since prior major surgery or open biopsy
- More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device)
- No concurrent major surgery
- No other concurrent therapy for breast cancer
- Concurrent bisphosphonates allowed if there is bone involvement
- No concurrent prophylactic granulocyte colony-stimulating factors
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00404404
Start Date
October 1 2006
Last Update
December 18 2013
Active Locations (1)
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1
Premiere Oncology
Santa Monica, California, United States, 90404