Status:
TERMINATED
A Phase II Study Of Abraxane and Nexavar in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
Veeda Oncology
Collaborating Sponsors:
Bayer
Celgene Corporation
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II, open-label, non-randomized study in patients with locally advanced or metastatic breast cancer. Each cycle will be 4 weeks in length. Patients will receive Abraxane weekly for 3 w...
Eligibility Criteria
Inclusion
- Patients must have signed an IRB-approved informed consent.
- Patients must have histologically confirmed locally advanced or metastatic breast cancer.
- Patients must be HER2-negative.
- Patients must have measurable disease, as defined by the RECIST criteria.
- Patients may have received prior adjuvant chemotherapy for breast cancer, including taxane-containing regimens, provided this treatment was completed at least 12 months prior to enrollment.
- Patients must be \<18 years of age.
- Patients must have an ECOG Performance Status of 0 or 1.
- Patients' estimated life expectancy must be at least 12 weeks.
- Patients must have adequate liver functions defined as: total bilirubin within normal limits and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 X upper limit of normal (ULN) (or \< 5 X ULN for patients with liver involvement).
- Patients must have alkaline phosphatase ≤ 2.5 X ULN. Alkaline phosphatase may be \> 2.5 x ULN if bone metastasis is present in the absence of liver metastasis, and the patient's bilirubin ≤ ULN.
- Patients must have adequate renal function defined as: creatinine ≤ 1.5 mg/dL.
- Patients must have adequate bone marrow function, including absolute neutrophil count (ANC) \>1500/µL, platelet count \>100,000/µL, and hemoglobin \>9 g/dL.
- Patients must have a normal baseline left ventricular ejection fraction (LVEF).
- Patients must be normotensive. Patients taking anti-hypertensive medication must have blood pressure controlled and not greater than 140/90.
- International Normalized Ratio (INR) \< 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits.
- Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months.
- Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter.
- Patients must be willing and able to comply with scheduled visits, treatment plan and laboratory testing, and be accessible for follow-up.
Exclusion
- Patients who have received prior chemotherapy for the treatment of locally advanced or metastatic breast cancer.
- Patients who have received prior Abraxane or Nexavar.
- Patients who have a history of hypersensitivity or a suspected allergy to taxanes, any of the components in taxanes, Abraxane, or Nexavar.
- Patients with serious intercurrent medical or psychiatric illness, including serious active infection.
- Patients with untreated or active brain metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Patients with a history of thrombosis.
- Patients with thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Patients with symptomatic congestive heart failure or a baseline echocardiogram with LVEF \< ULN.
- Patients with congestive heart failure \> class II New York Heart Association (NYHA). Patients must not have unstable angina (anginal symptoms at rest), or new onset angina (began within the last 3 months), or myocardial infarction within the past 6 months.
- Patients with cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Patients with a history of, or active, bowel perforation or inflammatory bowel disease.
- Patients with active peptic ulcer disease or symptoms to suggest possible ulcer (discontinuation of chronic NSAID therapy advised, or if not possible, use of proton-pump inhibitors recommended.)
- Patients planning to receive any concurrent therapy to treat locally advanced or metastatic breast cancer during the study treatment period.
- Any patient who is pregnant or lactating.
- Patients with proteinuria \> +1 by baseline dipstick, or if +2, 24-hour urine total protein \> 250 mg.
- Patients who have undergone major surgery, open biopsy, or significant traumatic injury within 28 days, or minor surgery within 14 days. (The placement of a Mediport or other vascular access device is permitted if performed at least 7 days prior to registration).
- Patients with \> Grade 2 peripheral neuropathy (NCI-CTC v3.0) or any painful neuropathy.
- Patients who have experienced any type of bone fracture within 12 months or who have undergone joint replacement surgery within 6 months.
- Patients with a serious non-healing wound.
- Patients with known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Patients requiring anticoagulants (with the exception of low-dose Coumadin, ASA, Plavix or Heparin for maintenance of vascular access patency).
- Patients with evidence or history of bleeding diathesis or coagulopathy.
- Patients experiencing any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Patients with pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Patients with any condition that impairs a patient's ability to swallow whole pills or patients with any malabsorption problems.
- Patients who use St. John's Wort or rifampin (rifampicin).
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00607438
Start Date
September 1 2007
End Date
May 1 2009
Last Update
May 11 2012
Active Locations (1)
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1
Veeda Oncology
Columbus, Ohio, United States, 43215