Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer

Stage IVA Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676818
• Other study ID #: 5C-11-2
• Secondary ID: NCI-2012-01378
• Status: Completed
• Phase: Phase 2
• Start date: August 9, 2012
• Est. completion date: August 9, 2021

Study information

• Verified date: November 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 9, 2021
• Est. primary completion date: February 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of invasive cervical cancer

• Measurable disease

• 0-1 prior chemotherapy regimens for recurrent or advanced disease; platinum based chemotherapy administered as a radiation sensitizer agent is allowed and does not count as prior therapy

• Absolute granulocyte count (AGC) >= 1,500

• Platelet >= 100,000

• Serum creatinine < 2.0 mg/dl

• Bilirubin =< 1.5 times the upper limit of the normal range (ULN)

• Alkaline phosphatase =< 3 x ULN (in the case of liver metastases, =< 5 x ULN)

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (in the case of liver metastases, =< 5 x ULN)

• Peripheral neuropathy grade 0-2

• Recovery of all chemotherapy or radiation-related toxicities to grade =< 1, except for alopecia and peripheral neuropathy

• Performance status 0-2

• Signed informed consent

Exclusion Criteria:

• Prior treatment with eribulin

• Chemotherapy, radiation, or biological or targeted therapy within 3 weeks

• Hormonal therapy within 1 week

• Any investigational drug within 4 weeks

• Known brain metastases, unless previously treated and asymptomatic for 3 months and not progressive in size or number for 3 months

Related Conditions & MeSH terms

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

Intervention

Drug:
• eribulin mesylate
Given IV

Locations

Country	Name	City	State
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	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
Primary	Number of participants with serious adverse events (SAEs)	The rate of grade 3+ hematologic and non-hematologic toxicities will be computed for course 1 and for all courses combined. Safety evaluation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.3.	Up to 2 years
Secondary	Best overall response (BOR)	Exact 95% binomial confidence intervals will be computed for the BOR rate. BOR defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to RECIST 1.1.	Up to 2 years
Secondary	Overall survival (OS)		From first day of treatment to time of death due to any cause, assessed up to 2 years