Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
I. To evaluate the activity of eribulin (eribulin mesylate) in the management of advanced or
recurrent cervical cancer (progression-free survival [PFS].
I. To describe the toxicity profile of eribulin in patients with advanced or recurrent
II. To estimate the survival of patients with advanced or recurrent cervical cancer treated
III. To evaluate potential correlative studies as predictive or prognostic makers in this
patient population (glucose-regulated protein 78 [GRP78] levels in tissue and blood, tumor
protein p53 [p53] expression, apoptosis with terminal deoxynucleotidyl transferase dUTP nick
end labeling [TUNEL] assay, apoptosis-related proteins B-cell lymphoma 2 [Bcl-2] and
Bcl2-associated X protein [Bax] using immunohistochemistry [IHC], proliferation with Ki-67
IHC, and expression levels of microtubule-associated variables, including tau protein, total
alpha- and beta-tubulin, and classes II-IV beta-tubulin isotopes with IHC.
OUTLINE: Patients receive eribulin mesylate 1.4 mg/m2 intravenously (IV) bolus over 2-5
minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Product limits estimates of 6-month PFS will be computed using all patients enrolled on the study. 95% confidence intervals will be based on Greenwood standard errors.
From the first day of treatment to the first observation of disease progression or death due to any cause, assessed at 6 months
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC Norris Comprehensive Cancer Center||Los Angeles, California 90089|