Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT01676818|
Recruitment Status : Recruiting
First Posted : August 31, 2012
Last Update Posted : April 20, 2017
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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, 2018|
|Estimated Study Completion Date :||August 9, 2019|
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
- 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.
- 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.
- 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.
- Overall survival (OS) [ Time Frame: From first day of treatment to time of death due to any cause, assessed up to 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676818
|Contact: Kristy Watkins, R.N.||323-865-0452||Kristy.Watkins@med.usc.edu|
|Contact: Grace Facio, RN||323-226-7027||Grace.Facio@med.usc.edu|
|United States, California|
|USC Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Principal Investigator: Lynda Roman, MD|
|Principal Investigator:||Lynda Roman, MD||University of Southern California|