Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-25
• Target enrollment: 0
• Participant gender: All

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 of the patient changes the way the drug works.

PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients of different ages with metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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