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NCT Number: NCT01676818

Eribulin Mesylate in Treating Patients With 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

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Key information

Conditions

Recurrent Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Stage IIIA Cervical Cancer Stage IIIB Cervical Cancer Stage IVA Cervical Cancer Stage IVB Cervical Cancer Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eribulin mesylate

Drug

Given IV

Other names: B1939, E7389, ER-086526, halichrondrin B analog

Primary outcomes

  1. Progression-free Survival

    Time frame: From the first day of treatment to the first observation of disease progression or death due to any cause, assessed at 6 months

    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.

  2. Number of Participants With Serious Adverse Events (SAEs)

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

    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.

Secondary outcomes

  1. Best Overall Response (BOR)

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

    BOR is defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.

  2. Overall Survival (OS)

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

    Overall survival is defined as the time from first day of treatment to time of death due to any cause. If a patient is still alive, survival time is censored at the time of last follow-up.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2012
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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