This phase II trial studies how well eribulin mesylate works in treating patients with cervical cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has come back (recurrent). Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01676818.
PRIMARY OBJECTIVES:
I. To evaluate the activity of eribulin (eribulin mesylate) in the management of advanced or recurrent cervical cancer (progression-free survival [PFS]).
SECONDARY OBJECTIVES:
I. To describe the toxicity profile of eribulin in patients with advanced or recurrent cervical cancer.
II. To estimate the survival of patients with advanced or recurrent cervical cancer treated with eribulin.
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 53 [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/m^2 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.
Lead OrganizationUSC / Norris Comprehensive Cancer Center
Principal InvestigatorLynda Diane Roman
