Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer

NCT01676818 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 5C-11-2NCI-2012-01378
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival

  Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death. It is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up.

  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)

  Safety evaluation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.3 was used to grade all SAEs. Grade 3+ hematologic and non-hematologic toxicities are reported.

  At study drug administration until 30 days following the last dose. Assessed up to 2 years.

Secondary Outcomes (2)

• Best Overall Response (BOR)

  Every 6 weeks from start of treatment until occurrence of progressive disease, assessed up to 4 years.

• Overall Survival (OS)

  From first day of treatment to time of death due to any cause, assessed up to 2 years

Study Arms (1)

Eribulin mesylate

EXPERIMENTAL

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

Interventions

eribulin mesylate DRUG

Given IV

Also known as: B1939, E7389, ER-086526, halichrondrin B analog

Eribulin mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of invasive cervical cancer
• Measurable disease
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Tali Homsey
• Organization: USC/Norris Comprehensive Cancer Center

tali.homsey@med.usc.edu

(323) 865-0451

Study Officials

• Lynda Roman, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: August 31, 2012
• Study Start: August 9, 2012
• Primary Completion: February 21, 2021
• Study Completion: December 22, 2021
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Locations

US (1)