Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Recurrent Cervical Cancer; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer; Stage IIIA Cervical Cancer; Stage IIIB Cervical Cancer
• Intervention / Treatment: Drug: eribulin mesylate

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Usc Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eribulin mesylate; Eribulin mesylate 1.4 mg/m2 IV bolus over 2-5 minutes on days 1 and 8 every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: eribulin mesylate; Given IV; Other Names: E7389; ER-086526; B1939; halichrondrin B analog

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall survival (OS)		From first day of treatment to time of death due to any cause, assessed up to 2 years

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lynda Roman, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2012
• Primary Completion (Actual): February 21, 2021
• Study Completion (Actual): August 9, 2021

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: August 30, 2012
• First Posted (Estimate): August 31, 2012

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; Uterine Cervical Neoplasms; Recurrence
• Other Study ID Numbers: 5C-11-2; NCI-2012-01378 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No