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A RANDOMIZED PHASE II TRIAL OF WEEKLY NANOPARTICLE ALBUMIN BOUND PACLITAXEL (NAB-PACLITAXEL) (NSC-736631) WITH OR WITHOUT BEVACIZUMAB, EITHER PRECEDED BY OR FOLLOWED BY Q 2 WEEK DOXORUBICIN (A) AND CY

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which treatment regimen is more effective in treating women with breast cancer. PURPOSE: This randomized phase II trial is studying paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, cyclophosphamide, and pegfilgrastim to compare how well they work when given with or without bevacizumab in treating women with inflammatory or locally advanced breast cancer.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Female

Eligibility

DISEASE CHARACTERISTICS:

- Histologically or pathologically confirmed breast cancer meeting one of the following
criteria:

- Locally advanced disease (stage IIIB disease, stage IIB/IIIA, or stage IIIC
disease)

- Inflammatory disease meeting the following two clinicopathologic criteria:

- Diffuse erythema AND edema (peau d'orange) of the breast involving the
majority of the skin of the breast, i.e., more than 50%

- A biopsy demonstrating cancer either within the dermal lymphatics OR in the
breast parenchyma itself

- HER2/neu-negative tumor as demonstrated by 0 or 1+ (weak or no staining) by DAKO,
IHC, or equivalent test OR no gene amplification by FISH*

- 2+ by DAKO or IHC allowed provided FISH* negative

- NOTE: *A negative FISH test ratio is < 1.8 or FISH HER2 gene copy < 4.0; if only a
positive or negative result is available from the FISH test, a negative result is
acceptable for study entry

- Hormone receptor status known

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- Zubrod performance status 0-2

- Granulocyte count > 1,500/mm^3

- ANC ≥ 1,500/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin 9.0 g/dL

- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 mg/dL

- ALT and AST ≤ 3 times ULN

- Alkaline phosphatase ≤ 2.5 ULN (unless bone metastasis is present in the absence of
liver metastasis)

- Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg on 24-hour urine
collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to take oral medications (e.g., no uncontrolled nausea, vomiting, or diarrhea,
lack of physical integrity of the upper gastrointestinal tract, or malabsorption
syndrome)

- QTc < 500 msec by EKG

- LVEF normal by MUGA or ECHO (for patients with hypertension or for patients > 60
years of age)

- NYHA class II cardiac function by baseline ECHO/MUGA (for patients who have received
central thoracic radiotherapy that included the heart in the radiotherapy port, or
for patients who have a history of class II heart failure but are asymptomatic on
treatment are eligible)

- No history of stroke (cerebrovascular accident), transient ischemic attack, or
cardiac event within the past 12 months, including any of the following:

- Myocardial infarction (including severe/unstable angina)

- Coronary/peripheral artery bypass graft

- Symptomatic congestive heart failure

- Pulmonary embolism

- No poorly controlled hypertension, defined as recurrent or persistent (≥ 24 hours)
elevated blood pressure (i.e., systolic blood pressure ≥ 140 mm Hg and/or diastolic
blood pressure ≥ 90 mm Hg)

- No other malignancy within the past 5 years except for adequately treated basal cell
or squamous cell skin cancer or in situ cervical cancer

- Peripheral neuropathy < grade 2

PRIOR CONCURRENT THERAPY:

- No prior tyrosine kinase inhibitors

- More than 5 years since prior chemotherapy, radiotherapy, or biologic therapy (e.g.,
trastuzumab or bevacizumab) for invasive breast cancer

- At least 7 days since prior hormonal therapy

- At least 7 days since prior and no concurrent strong CYP3A4 inhibitors (e.g.,
ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone,
nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or grapefruit juice

- No concurrent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine,
rifampin, rifabutin, rifapentin, phenobarbital, St. John's wort)

- No other concurrent therapy for the treatment of breast cancer except for
bisphosphonates

- No concurrent brachytherapy

Gender: Female
Steward Physician(s)
  • Zeina Nahleh, MD
Facilities
  • St. Elizabeth's Medical Center - Recruiting
Trial Interventions
Biological
  • bevacizumab
  • pegfilgrastim
Drug
  • cyclophosphamide
  • doxorubicin hydrochloride
  • paclitaxel albumin-stabilized nanoparticle formulation
For more information about this trial, contact

Dorcas Chi

Phone: 617-789-3000

Dorcas Chi

Phone: (617) 789-3000


Physician Researcher

Investigator Name:

  • Zeina Nahleh, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00856492
Volunteers:  Not Accepting Healthy Volunteers

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