NCT01676818

Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer

Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well eribulin mesylate works in treating patients with advanced or recurrent cervical cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

Detailed description

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 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.

Conditions

• Recurrent Cervical Cancer
• Stage IIIA Cervical Cancer
• Stage IIIB Cervical Cancer
• Stage IVA Cervical Cancer
• Stage IVB Cervical Cancer

Interventions

Type	Name	Description
DRUG	eribulin mesylate	Given IV

Timeline

• Start date: 2012-08-09
• Primary completion: 2021-02-21
• Completion: 2021-12-22
• First posted: 2012-08-31
• Last updated: 2025-11-06
• Results posted: 2025-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study