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Trial record 41 of 157 for:    eribulin

Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01676818
Recruitment Status : Active, not recruiting
First Posted : August 31, 2012
Last Update Posted : May 25, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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

Condition or disease Intervention/treatment Phase
Recurrent Cervical Cancer Stage IIIA Cervical Cancer Stage IIIB Cervical Cancer Stage IVA Cervical Cancer Stage IVB Cervical Cancer Drug: eribulin mesylate Phase 2

Detailed Description:


I. To evaluate the activity of eribulin (eribulin mesylate) in the management of advanced or recurrent cervical cancer (progression-free survival [PFS].


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
Actual Study Start Date : August 9, 2012
Estimated Primary Completion Date : August 9, 2019
Estimated Study Completion Date : August 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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:
  • B1939
  • E7389
  • ER-086526
  • halichrondrin B analog

Primary Outcome Measures :
  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 ]
    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.

  2. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 2 years ]
    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.

Secondary Outcome Measures :
  1. Best overall response (BOR) [ Time Frame: Up to 2 years ]
    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.

  2. Overall survival (OS) [ Time Frame: From first day of treatment to time of death due to any cause, assessed up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01676818

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United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
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Principal Investigator: Lynda Roman, MD University of Southern California

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Responsible Party: University of Southern California Identifier: NCT01676818     History of Changes
Other Study ID Numbers: 5C-11-2
NCI-2012-01378 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female