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Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Metastatic Breast Cancer


Phase 2
65 Years
N/A
Open (Enrolling)
Both
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

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Trial Information

Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Metastatic Breast Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Description:

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.

Outcome Time Frame:

30 days after completion of last course of study treatment

Safety Issue:

Yes

Principal Investigator

Arti Hurria

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Institutional Review Board

Study ID:

11139

NCT ID:

NCT01463072

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male

Name

Location
City of Hope Medical Center Duarte, California  91010
South Pasadena Cancer Center South Pasadena, California  91030