Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT01676818
Status:
COMPLETED
Last Update Posted:
2025-11-06
First Post:
2012-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-01378 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |