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Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics



- 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.


- 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

Inclusion Criteria


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


- 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Age-related changes in the pharmacokinetics (pK)

Outcome Time Frame:

Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours

Safety Issue:


Principal Investigator

Arti Hurria, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • male breast cancer
  • Breast Neoplasms



City of Hope Comprehensive Cancer Center Duarte, California  91010
City of Hope Medical Group Pasadena, California  91105