Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Older Patients With Metastatic Breast Cancer

This study is currently recruiting participants.
Verified February 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01463072
First received: October 25, 2011
Last updated: February 10, 2014
Last verified: February 2014

October 25, 2011
February 10, 2014
June 2012
May 2015   (final data collection date for primary outcome measure)
Tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, dose reductions, delays or interruptions) using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4.0 [ Time Frame: 30 days after completion of last course of study treatment ] [ Designated as safety issue: Yes ]
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated. Tables will be created to summarize the toxicities and side effects by course, organ, and severity for all patients. We will describe toxicities on a patient by patient basis. Numbers of courses received and dose reductions will be tabulated.
Tolerability (grade 3-5 toxicity, neuropathy grade 2 or higher, dose reductions, delays or interruptions) using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4.0 [ Time Frame: 30 days after completion of last course of study treatment ] [ Designated as safety issue: Yes ]
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated. Tables will be created to summarize the toxicities and side effects by course, organ, and severity for all patients. We will describe toxicities on a patient by patient basis. Numbers of courses received and dose reductions will be tabulated.
Complete list of historical versions of study NCT01463072 on ClinicalTrials.gov Archive Site
  • Determination of efficacy based upon best response to treatment and time to disease progression [ Time Frame: 30 days after completion of last course of study treatment ] [ Designated as safety issue: No ]
    Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for objective response rate (complete response [CR] + partial response [PR]) and clinical benefit rate (CR + PR + stable disease [SD]) as determined by Response Evaluation Criteria in Solid Tumors (RECIST). Progression free survival will be estimated using the product limit method of Kaplan and Meier.
  • Use of a cancer-specific geriatric assessment to predict the need for dose reduction, dose delays, or occurence of grade 2-5 toxicity and neuropathy grade 2 or higher. [ Time Frame: 30 days after completion of last course of study treatment ] [ Designated as safety issue: No ]
    General linear models and graphical methods will be used to explore factors as identified by a cancer-specific geriatric assessment that may be predictive of toxicity/dose reduction or dose delays. Assessment consists of an evaluation of the individual's functional status, comorbid medical conditions, cognition, nutritional status, psychological state, and social support.
  • Determination of efficacy based upon best response to treatment and time to disease progression [ Time Frame: 30 days after completion of last course of study treatment ] [ Designated as safety issue: No ]
  • Use of a cancer-specific geriatric assessment to predict the need for dose reduction, dose delays, or occurence of grade 3-5 toxicity and neuropathy grade 2 or higher. [ Time Frame: 30 days after completion of last course of study treatment ] [ Designated as safety issue: No ]
    General linear models and graphical methods will be used to explore factors as identified by a cancer-specific geriatrics assessment that may be predictive of toxicity/dose reduction or dose delays.
Not Provided
Not Provided
 
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Older Patients With Metastatic Breast Cancer
Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Metastatic Breast Cancer

This phase II trial studies the side effects of paclitaxel albumin-stabilized nanoparticle formulation in treating older patients with metastatic breast cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PRIMARY OBJECTIVES:

I. To evaluate the tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, need for dose reductions, or delays) of weekly nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) in older adults with metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy (response and time to progression) of weekly nab-paclitaxel in older adults with metastatic breast cancer using a stratification factor based on patient age (at least 5 patients age 75 years or older and no more than 15 patients age 65-70 years).

II. To explore predictors of the need for dose reduction, dose delays, or grade 2-5 toxicity and neuropathy grade 2 or higher based on a cancer-specific geriatric assessment.

OUTLINE:

Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
    Given IV
    Other Names:
    • ABI-007
    • nab paclitaxel
    • nab-paclitaxel
    • nanoparticle albumin-bound paclitaxel
  • Other: questionnaire administration
    Ancillary studies
Experimental: Treatment (chemotherapy)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
  • Other: questionnaire administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Metastatic breast cancer
  • Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel alone
  • First or second line chemotherapy treatment for metastatic disease
  • Karnofsky Performance Scale (KPS) >= 70%
  • Resolution of grade >= 2 toxicity from prior therapy (other than alopecia)
  • Peripheral neuropathy =< grade 1
  • White blood cell count >= 3,000 cells/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin (Hb) >= 9.0g/dl
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal
  • Alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases
  • Bilirubin =< 1.5mg/dl
  • Creatinine clearance (calculated or 24 hour) >= 30ml/min
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents
  • Untreated central nervous system (CNS) metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids
  • Known history of allergic reactions to paclitaxel
  • Presence of any serious or uncontrolled infection
  • Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
Both
65 Years and older
No
Not Provided
United States
 
NCT01463072
11139, NCI-2011-03295
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Arti Hurria City of Hope Medical Center
City of Hope Medical Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP