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

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT00609791

This phase II trial examines age-related pharmacokinetics and pharmacodynamics of nab-paclitaxel in metastatic breast cancer patients. Eligible participants receive the drug intravenously on a 28-day cycle. The study includes pharmacological, physiological, and cognitive assessments, alongside questionnaires on socioeconomic and demographic factors, to explore predictors of treatment response and toxicity.

Patient Parameters

Parameter	Options

Program Overview

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.

Description

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.

Eligibility 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 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

Locations

FACILITY	ZIP	CITY	STATE
City of Hope Medical Center	91010-3000	Duarte	California
City of Hope Medical Group	91105	Pasadena	California

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