Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Southern California
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01676818
First received: August 29, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    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:
  • Best overall response (BOR) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.

  • Overall survival (OS) [ Time Frame: From first day of treatment to time of death due to any cause, assessed up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676818

Locations
United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Agustin A. Garcia    323-865-0451    aagarcia@usc.edu   
Principal Investigator: Agustin A. Garcia         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Agustin Garcia University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01676818     History of Changes
Other Study ID Numbers: 5C-11-2, NCI-2012-01378
Study First Received: August 29, 2012
Last Updated: July 21, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 26, 2014