A Phase II Trial of Trastuzumab, Neupogen, and Vinorelbine Investigating the Effects on Immune Function and Clinical Outcomes in Patients With Metastatic Breast Cancer Overexpressing Her-2/Neu
This is a randomized phase II study comparing trastuzumab with G-CSF against trastuzumab
with placebo during the first two weeks of therapy.
Twenty five patients with metastatic breast cancer will be randomized to receive weekly
trastuzumab plus either G-CSF or placebo by subcutaneous (SQ) injection daily for five days
weekly for two weeks. Subsequently, all patients will receive an additional 12 weeks of
weekly trastuzumab, G-CSF by SQ injection daily for five days weekly for 12 weeks, and
vinorelbine once weekly at a dose of 25 mg/m2 weeks 3, 4, 6, 7, 9, 10, 12, 13. Baseline
evaluation will include a history and physical exam, comprehensive metabolic panel (CMP),
complete blood count (CBC), serum pregnancy test, computerized tomography (CT) scan for
disease measurements, and a Multiple Uptake Gated Acquisition (MUGA) scan. The CT scan and
MUGA will be repeated upon completion of the study treatment. Blood will be drawn
pre-trastuzumab, 2 hours post-trastuzumab, and 48 hours post-trastuzumab on weeks 1, 2, 3,
4, and 12 to measure whole blood ADCC activity. Two additional assays for whole blood ADCC
activity will be drawn at baseline pre-treatment, and following completion of protocol
treatment. These assays will measure chromium release from a Her-2 positive target cell
exposed to the patient's effector cells. Measurement of soluble Her-2 in patient serum will
also be measured at each ADCC time point.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
To compare antibody dependent cell-mediated cytotoxicity of effector cells isolated from subjects receiving trastuzumab with either G-CSF or a saline placebo against a Her-2 overexpressing target in vitro
Two weeks
No
Gary N Schwartz, MD
Principal Investigator
Norris Cotton Cancer Center
United States: Institutional Review Board
D-0140
NCT00169104
July 2002
March 2009
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