Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer

OBJECTIVES:

Primary

- To determine age-related changes in the pharmacokinetics (pK) of weekly paclitaxel
albumin-stabilized nanoparticle formulation (nab-paclitaxel) in patients with metastatic
breast cancer.

- To determine age-related changes in the pharmacodynamics (toxicity) of nab-paclitaxel in
these patients.

Secondary

- To determine response and time to progression in these patients.

- To explore predictors of pK parameters in these patients.

- To explore predictors of the need for dose reduction, dose delays, or grade 3 or 4
toxicity in these patients.

OUTLINE: Patients are stratified by age in years (< 50 vs 50-60 vs 60-70 vs > 70).

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes
once daily on days 1, 8, and 15 as planned. Treatment repeats every 28 days in the absence of
disease progression or unacceptable toxicity.

Blood is drawn for pharmacokinetic studies periodically during course 1.

Patients complete questionnaires regarding risk factors that would predict for
pharmacokinetic parameters at baseline, prior to the third course of treatment, and at end of
study. Data collected include medical characteristics, demographics, functional status,
comorbidity, psychological status, social functioning and support, nutritional status, and
cognition.

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