Status:
ACTIVE_NOT_RECRUITING
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 o...
Detailed Description
OBJECTIVES: Primary * To determine age-related changes in the pharmacokinetics (pK) of weekly paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in patients with metastatic brea...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
- No known history of allergic reactions to paclitaxel
- No serious or uncontrolled infection
- Ability to understand and the willingness to sign a written informed consent document
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No ≥ grade 2 toxicity from prior therapy (other than alopecia)
- No taxane for adjuvant therapy or metastatic disease within the past 12 months
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
February 11 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00609791
Start Date
February 11 2008
End Date
April 24 2026
Last Update
June 19 2025
Active Locations (2)
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1
City of Hope Medical Center
Duarte, California, United States, 91010-3000
2
City of Hope Medical Group
Pasadena, California, United States, 91105