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

NCT ID: NCT00609791

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-11
• Study Completion Date: 2026-04-24

Brief 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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nab-paclitaxel

Group Type: EXPERIMENTAL

paclitaxel albumin-stabilized nanoparticle formulation

Intervention Type: DRUG

100 mg/m2 3 weeks on 1 week off

pharmacological study

Intervention Type: OTHER

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

physiologic testing

Intervention Type: OTHER

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

questionnaire administration

Intervention Type: OTHER

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

study of socioeconomic and demographic variables

Intervention Type: OTHER

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

cognitive assessment

Intervention Type: PROCEDURE

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

psychosocial assessment and care

Intervention Type: PROCEDURE

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

Interventions

paclitaxel albumin-stabilized nanoparticle formulation

100 mg/m2 3 weeks on 1 week off

Intervention Type: DRUG

pharmacological study

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

Intervention Type: OTHER

physiologic testing

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

Intervention Type: OTHER

questionnaire administration

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

Intervention Type: OTHER

study of socioeconomic and demographic variables

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

Intervention Type: OTHER

cognitive assessment

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

Intervention Type: PROCEDURE

psychosocial assessment and care

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mina Sedrak, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

City of Hope Medical Group

Pasadena, California, United States

Countries

United States

References

Hurria A, Blanchard MS, Synold TW, Mortimer J, Chung CT, Luu T, Katheria V, Rotter AJ, Wong C, Choi A, Feng T, Ramani R, Doan CM, Brown J, Somlo G. Age-related changes in nanoparticle albumin-bound paclitaxel pharmacokinetics and pharmacodynamics: influence of chronological versus functional age. Oncologist. 2015 Jan;20(1):37-44. doi: 10.1634/theoncologist.2014-0202. Epub 2014 Dec 9.

Reference Type: DERIVED

PMID: 25492923 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-07157

Identifier Type: -

Identifier Source: secondary_id

ABRAXIS-ABX206-BC07US

Identifier Type: -

Identifier Source: secondary_id

CDR0000586461

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2011-02403

Identifier Type: REGISTRY

Identifier Source: secondary_id

07157

Identifier Type: -

Identifier Source: org_study_id