Study on Paclitaxel Albumin-Stabilized Nanoparticle Formulation for Treating Metastatic Breast Cancer in Patients of Different Ages
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT00609791
This clinical trial is examining how a specific formulation of the drug paclitaxel works in treating metastatic breast cancer in patients of various ages. The study aims to understand how age affects the drug's effectiveness and side effects.
Patient Parameters
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Program Overview
The purpose of this study is to learn how well a special formulation of the drug paclitaxel, called paclitaxel albumin-stabilized nanoparticle formulation, works in treating metastatic breast cancer in patients of different ages. Researchers want to see if age affects how the drug is processed in the body and its side effects.
Description
The main goals of this study are to understand how age affects the way the body processes and reacts to the drug paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in patients with metastatic breast cancer. Researchers will look at how the drug moves through the body and its side effects in patients of different age groups.
Secondary goals include observing how patients respond to the treatment and how long it takes for the cancer to progress. The study will also explore factors that might predict how the drug is processed and whether patients need dose adjustments due to side effects.
Patients are divided into age groups: under 50, 50-60, 60-70, and over 70. They will receive the drug through an IV infusion over 30 minutes on days 1, 8, and 15 of each 28-day cycle, as long as the cancer does not worsen and side effects are manageable.
Blood samples will be taken during the first treatment cycle to study how the drug is processed. Patients will also fill out questionnaires about their health, lifestyle, and support systems at the start, before the third treatment cycle, and at the end of the study.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with metastatic breast cancer
- Any status of estrogen receptor, progesterone receptor, or HER-2/neu is allowed if receiving paclitaxel albumin-stabilized nanoparticle formulation alone
- Planned as first- or second-line chemotherapy treatment for metastatic disease
Exclusion Criteria
- Untreated or worsening brain metastases requiring increasing doses of steroids
Patient Characteristics:
- General health status (Karnofsky performance) between 70-100%
- White blood cell count of at least 3,000/mm³
- Neutrophil count of at least 1,500/mm³
- Platelet count of at least 100,000/mm³
- Hemoglobin level of at least 9.0 g/dL
- Liver enzymes (AST and ALT) no more than 2.5 times the normal limit
- Alkaline phosphatase no more than 2.5 times the normal limit unless bone metastases are present without liver metastases
- Bilirubin level no more than 1.5 mg/dL
- Peripheral neuropathy no worse than grade 1
- Kidney function (creatinine clearance) of at least 30 mL/min
- Negative pregnancy test
- Fertile patients must use effective birth control
- Not pregnant or breastfeeding
- No known allergies to paclitaxel
- No serious or uncontrolled infections
- Ability to understand and sign a consent form
Prior or Concurrent Therapy:
- No severe side effects (grade 2 or higher) from previous treatments, except hair loss
- No taxane treatment for breast cancer in the past 12 months
- Not participating in other experimental treatments
- No other cancer treatments at the same time
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010-3000 | Duarte | California |
| City of Hope Medical Group | 91105 | Pasadena | California |
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