Text Size

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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00609791
First received: February 6, 2008
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 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
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: January 2008
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609791

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Arti Hurria, MD Beckman Research Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00609791     History of Changes
Other Study ID Numbers: 07157, P30CA033572, CHNMC-07157, ABRAXIS-ABX206-BC07US, CDR0000586461
Study First Received: February 6, 2008
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
recurrent breast cancer
stage IV breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013