Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments paclitaxel albumin-stabilized nanoparticle formulation, pharmacological study, physiologic testing, questionnaire administration, study of socioeconomic and demographic variables, cognitive assessment, psychosocial assessment and care
Phase phase 2
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date January 2008
End date August 2017
Trial size 40 participants
Trial identifier NCT00609791, 07157, ABRAXIS-ABX206-BC07US, CDR0000586461, CHNMC-07157, P30CA033572

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
paclitaxel albumin-stabilized nanoparticle formulation
100 mg/m2 3 weeks on 1 week off
pharmacological study
Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours
physiologic testing
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
questionnaire administration
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
study of socioeconomic and demographic variables
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
cognitive assessment
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy
psychosocial assessment and care
Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Primary Outcomes

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
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics
Principal investigator Arti Hurria, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.