Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00609791|
Recruitment Status : Active, not recruiting
First Posted : February 7, 2008
Last Update Posted : September 6, 2017
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 or disease||Intervention/treatment||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|
- 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.
- 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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics|
|Actual Study Start Date :||January 25, 2008|
|Estimated Primary Completion Date :||August 20, 2018|
|Estimated Study Completion Date :||August 20, 2018|
Drug: paclitaxel albumin-stabilized nanoparticle formulation
100 mg/m2 3 weeks on 1 week offOther: pharmacological study
Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hoursOther: physiologic testing
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapyOther: questionnaire administration
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapyOther: study of socioeconomic and demographic variables
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapyProcedure: cognitive assessment
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapyProcedure: psychosocial assessment and care
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
- 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 ]
- 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 ]
- Response [ Time Frame: Assessed after every 2 cycles of therapy until progression ]
- Time to progression [ Time Frame: 1 year after completion of treatment ]
- Predictors of pK parameters [ Time Frame: After week 1 of treatment ]
- Predictors of the need for dose reduction, dose delays, or grade 3 or 4 toxicity [ Time Frame: At the completion of treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609791
|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|
|Principal Investigator:||Arti Hurria, MD||City of Hope Comprehensive Cancer Center|