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

NCT00609791 | Active Not Recruiting Phase 2 Results DMC

• 6 other identifiers: 07157P30CA033572CHNMC-07157ABRAXIS-ABX206-BC07USCDR0000586461NCI-2011-02403
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (2)

• Mean Area Under the Curve Over 24 Hours (AUC24)

  Mean of area under the curve over 24 hours (AUC24) reported as well as linear regression of AUC24 by age and chemotherapy toxicity risk score. Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19: patient age (\>=72 years); creatinine clearance (\<34 mL/min); presence of amenia (\<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type

  Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

• Mean Clearance (CL)

  Mean CL reported as well as regression results of CL by age and chemotherapy toxicity risk score. Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19: patient age (\>=72 years); creatinine clearance (\<34 mL/min); presence of amenia (\<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type

  Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

Secondary Outcomes (6)

• Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score

  Up to 2.5 years

• Best Response

  Assessed after every 2 cycles of therapy until progression, up to 2.5 years

• Median Event-free Survival (EFS) in Months

  From the date treatment begins until the first date on which recurrence, progression or death due to any cause, assessed up to 3.5 years

• Number of Participants Requiring Dose Reductions

  At the completion of treatment, up to 2.5 years

• Number of Participants With a Dose Omission

  At the completion of treatment, up to 2.5 years

Study Arms (1)

nab-paclitaxel

EXPERIMENTAL

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

Interventions

paclitaxel albumin-stabilized nanoparticle formulation DRUG

100 mg/m2 3 weeks on 1 week off

nab-paclitaxel

pharmacological study OTHER

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

nab-paclitaxel

physiologic testing OTHER

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

nab-paclitaxel

questionnaire administration OTHER

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

nab-paclitaxel

study of socioeconomic and demographic variables OTHER

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

nab-paclitaxel

cognitive assessment PROCEDURE

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

nab-paclitaxel

psychosocial assessment and care PROCEDURE

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

nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

Related Publications (1)

• 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.

  PMID: 25492923 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Taxes; Mental Status and Dementia Tests; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Mina Sedrak
• Organization: City of Hope

msedrak@coh.org

6263598111

Study Officials

• Mina Sedrak, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 7, 2008
• Study Start: February 11, 2008
• Primary Completion: October 25, 2011
• Study Completion: April 24, 2026
• Last Updated: June 19, 2025
• Results First Posted: August 9, 2022

Record last verified: 2025-06

Locations

US (2)