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NCT Number: NCT00609791

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Neoplasms, Male Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

City of Hope Medical Center, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel albumin-stabilized nanoparticle formulation

Drug

100 mg/m2 3 weeks on 1 week off

pharmacological study

Other

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

Physiologic Testing

Other

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Questionnaire Administration

Other

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

study of socioeconomic and demographic variables

Other

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

cognitive assessment

Procedure

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

psychosocial assessment and care

Procedure

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Primary outcomes

  1. Mean Area Under the Curve Over 24 Hours (AUC24)

    Time frame: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

    Mean of area under the curve over 24 hours (AUC24) reported as well as linear regression of AUC24 by age and chemotherapy toxicity risk score.

    Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19:

    patient age (>=72 years); creatinine clearance (<34 mL/min); presence of amenia (<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type

  2. Mean Clearance (CL)

    Time frame: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

    Mean CL reported as well as regression results of CL by age and chemotherapy toxicity risk score.

    Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19:

    patient age (>=72 years); creatinine clearance (<34 mL/min); presence of amenia (<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type

Secondary outcomes

  1. Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score

    Time frame: Up to 2.5 years

    Comparison of presence of grade 3 toxicity rate by risk score distribution.

    Chemotherapy toxicity risk score is based on the following variables. Higher scores indicate more risk, range of 2-19:

    patient age (>=72 years); creatinine clearance (<34 mL/min); presence of amenia (<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type

    Chemotherapy toxicity risk score category:

    Low risk score - toxicity risk score: 0-5 Medium risk score - toxicity risk score: 6-9 High risk score - toxicity risk score: 10-19

  2. Best Response

    Time frame: Assessed after every 2 cycles of therapy until progression, up to 2.5 years

    Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

    Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

  3. Median Event-free Survival (EFS) in Months

    Time frame: From the date treatment begins until the first date on which recurrence, progression or death due to any cause, assessed up to 3.5 years

    Median and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for EFS. EFS will be estimated using the product limit method of Kaplan and Meier.

    EFS is defined by time to disease recurrence, disease progression or death to due to any cause

  4. Number of Participants Requiring Dose Reductions

    Time frame: At the completion of treatment, up to 2.5 years

    Number of participants requiring a dose reduction is reported and analysis was performed using a student's 2 sample t test to determine the need of dose reductions based on age, AUC, and CL.

  5. Number of Participants With a Dose Omission

    Time frame: At the completion of treatment, up to 2.5 years

    Number of participants with a dose omission is reported and analysis was performed using a student's 2 sample t test to determine the need of dose omission based on age, AUC, and CL.

  6. Percent of Participants With a Grade 3 Toxicity

    Time frame: At the completion of treatment, up to 2.5 years

    Percent of participants experiencing a grade 3 toxicity is reported and analysis was performed using a student's 2 sample t test to determine the presence of grade 3 toxicity based on age, AUC, and CL.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2027
First posted
Feb 7, 2008
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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