Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: paclitaxel albumin-stabilized nanoparticle formulation; pharmacological study; physiologic testing; questionnaire administration; study of socioeconomic and demographic variables; cognitive assessment; psychosocial assessment and care
Intervention description: 100 mg/m2 3 weeks on 1 week off; Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours; Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy; Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy; Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy; Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy; Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage IV breast cancer; male breast cancer

Summary:

      RATIONALE: Gathering information from patients of different ages receiving paclitaxel
      albumin-stabilized nanoparticle formulation for metastatic breast cancer may help doctors
      understand how the age of the patient changes the way the drug works.

      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle
      formulation works in treating patients of different ages with metastatic breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

        Inclusion criteria:

          -  Diagnosis of metastatic breast cancer

          -  Any estrogen receptor, progesterone receptor, or HER-2/neu status allowed as long as
             the patient will receive paclitaxel albumin-stabilized nanoparticle formulation alone

          -  First- or second-line chemotherapy treatment for metastatic disease planned

        Exclusion criteria:

          -  Untreated CNS metastases or symptomatic CNS metastases requiring escalating doses of
             corticosteroids

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  WBC ≥ 3,000/mm³

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9.0 g/dL

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastases are present in the
             absence of liver metastases)

          -  Bilirubin ≤ 1.5 mg/dL

          -  Peripheral neuropathy ≤ grade 1

          -  Creatinine clearance ≥ 30 mL/min (calculated or 24-hour)

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Not pregnant or nursing

          -  No known history of allergic reactions to paclitaxel

          -  No serious or uncontrolled infection

          -  Ability to understand and the willingness to sign a written informed consent document

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No ≥ grade 2 toxicity from prior therapy (other than alopecia)

          -  No taxane for adjuvant therapy or metastatic disease within the past 12 months

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy