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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00609791
First received: February 6, 2008
Last updated: January 24, 2014
Last verified: January 2014

February 6, 2008
January 24, 2014
January 2008
October 2015   (final data collection date for primary outcome measure)
  • Age-related changes in the pharmacokinetics (pK) [ Time Frame: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours ] [ Designated as safety issue: No ]
  • Age-related changes in the pharmacodynamics (toxicity) [ Time Frame: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours ] [ Designated as safety issue: Yes ]
  • Age-related changes in the pharmacokinetics (pK) [ Designated as safety issue: No ]
  • Age-related changes in the pharmacodynamics (toxicity) [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00609791 on ClinicalTrials.gov Archive Site
  • Response [ Time Frame: Assessed after every 2 cycles of therapy until progression ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 1 year after completion of treatment ] [ Designated as safety issue: No ]
  • Predictors of pK parameters [ Time Frame: After week 1 of treatment ] [ Designated as safety issue: No ]
  • Predictors of the need for dose reduction, dose delays, or grade 3 or 4 toxicity [ Time Frame: At the completion of treatment ] [ Designated as safety issue: Yes ]
  • Response [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Predictors of pK parameters [ Designated as safety issue: No ]
  • Predictors of the need for dose reduction, dose delays, or grade 3 or 4 toxicity [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer
Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics

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.

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.

Interventional
Phase 2
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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
Experimental: nab-paclitaxel
Interventions:
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
  • Other: pharmacological study
  • Other: physiologic testing
  • Other: questionnaire administration
  • Other: study of socioeconomic and demographic variables
  • Procedure: cognitive assessment
  • Procedure: psychosocial assessment and care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Not Provided
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00609791
07157, P30CA033572, CHNMC-07157, ABRAXIS-ABX206-BC07US, CDR0000586461
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Arti Hurria, MD Beckman Research Institute
City of Hope Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP