Paclitaxel albumin-stabilized nanoparticle formulation and pharmacological study and physiologic testing in Breast Cancer - Clinical Trials Registry

Study Overview

Status

Active, not recruiting

Conditions

Breast Cancer

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Duarte, California, United States, 91010-3000
    - City of Hope Medical Center
  - Pasadena, California, United States, 91105
    - City of Hope Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nab-paclitaxel	Drug: paclitaxel albumin-stabilized nanoparticle formulation 100 mg/m2 3 weeks on 1 week off Other: pharmacological study Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours Other: physiologic testing Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy Other: questionnaire administration Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy Other: study of socioeconomic and demographic variables Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy Procedure: cognitive assessment Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy Procedure: psychosocial assessment and care Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Participant Group / Arm

Intervention / Treatment

Experimental: nab-paclitaxel

Drug: paclitaxel albumin-stabilized nanoparticle formulation

100 mg/m2 3 weeks on 1 week off

Other: pharmacological study

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

Other: physiologic testing