Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT01463072
This phase II trial evaluates the tolerability and efficacy of weekly IV nab-paclitaxel in older adults with locally advanced or metastatic breast cancer. Eligibility includes specific performance status and lab criteria. Interventions involve drug administration, laboratory biomarker analysis, and questionnaire administration. The study aims to assess toxicity, response, and progression time.
Patient Parameters
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Program Overview
This phase II trial studies the side effects of nab-paclitaxel in treating older patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Description
PRIMARY OBJECTIVE:
I. To evaluate the tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, need for dose reductions, or delays) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy (response and time to progression) of weekly nab-paclitaxel in older adults with locally advanced or 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 nab-paclitaxel intravenously (IV) over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Eligibility Criteria
Inclusion Criteria
- Locally advanced or 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 status (KPS) >= 70%
- Resolution of grade >= 2 toxicity from prior therapy (other than alopecia)
- Peripheral neuropathy =< grade 1
- Absolute neutrophil count >= 1,500/mm^3
- Platelets >= 100,000 cells/mm^3
- Hemoglobin (Hb) >= 9.0 g/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 =< 1.5 mg/dl
- Creatinine clearance (calculated or 24 hour) >= 30 ml/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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope medical | 91010 | Duarte | California |
| City of Hope Antelope Valley | 93534 | Lancaster | California |
| City of Hope South Pasadena | 91030 | South Pasadena | California |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
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