Status:
COMPLETED
Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Estrogen Receptor-negative Breast Cancer
HER2-negative Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib hydrochloride work i...
Detailed Description
PRIMARY OBJECTIVES: I. Progression free survival. SECONDARY OBJECTIVES: I. Response rate. II. Overall survival. III. Safety and toxicity. IV. Exploratory biomarkers will be assessed as potential...
Eligibility Criteria
Inclusion
- Have histologically confirmed invasive breast cancer that is estrogen receptor (ER) negative (=\< 10%), progesterone receptor (PR) negative (=\< 10%) and human epidermal growth factor receptor 2 (HER2) normal (=\< 10% of cells) by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
- Be receiving first-line therapy for metastatic disease
- Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration
- OR non-measurable disease only, with rising serum cancer antigen (CA)15-3 or CA 27.29 or carcinoembryonic antigen (CEA) documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration; the second CA 15-3 or CA 27.29 or CEA value must have at least a 20% increase over the first and for CA 15-3 or CA 27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL
- Subjects with brain metastases as their first site of disease recurrence may be eligible if treated by definitive radiation (stereotactic radiosurgery or whole brain) with clinically controlled neurologic symptoms for a period of 21 days prior to study treatment
- Bilirubin =\< 1.5 mg/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
- Alkaline phosphatase =\< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
- Platelets \> 100,000 cells/mm\^3
- Hemoglobin \> 9.0 g/dL
- Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
- Creatinine =\< 1.5 mg/dL is recommended; however, institutional norms are acceptable
- If of childbearing potential must have a negative pregnancy test and use an effective method to avoid pregnancy for the duration of the trial and for at least 6 months after completion of study therapy
- Pre-existing peripheral neuropathy, if present, must be \< grade 2 (per Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0)
- Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines
Exclusion
- Recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane
- Central nervous system (CNS) metastases that are symptomatic and/or requiring steroids
- Pre-existing nephritic syndrome
- Serious intercurrent medical or psychiatric illness including serious active infection
- Inadequately controlled hypertension (defined as systolic blood pressure \> 150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Proteinuria at screening as demonstrated by either:
- Urine protein:creatinine (UPC) ratio \>= 1.0 at screening OR
- Urine dipstick for proteinuria \> 2+ (patients discovered to have \> 2+ proteinuria on dipstick urinalysis at baseline must have a UPC ratio done that is \< 1.0 to be eligible; if the UPC ratio is \>= 1.0 then the patient should undergo a 24-hour urine collection which must demonstrate =\< 1 g of protein in 24 hours for the patient to be eligible)
- Known hypersensitivity to any component of bevacizumab or to nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation)
Key Trial Info
Start Date :
April 23 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2017
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00733408
Start Date
April 23 2008
End Date
September 28 2017
Last Update
December 4 2018
Active Locations (17)
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1
Anchorage Oncology Centre
Anchorage, Alaska, United States, 99508
2
Katmai Oncology Group
Anchorage, Alaska, United States, 99508
3
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
4
Yuma Cancer Center
Yuma, Arizona, United States, 85364