Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer
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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 |
- 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.
- 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 2015 |
| Estimated Primary Completion Date: | August 2014 (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:
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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 |
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| 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 | |
| Principal Investigator: | Agustin Garcia | USC/Norris Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | USC/Norris Comprehensive Cancer Center |
| 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: | March 6, 2013 |
| 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 May 23, 2013