Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
18 Years
N/A
Female
Recurrent Cervical Cancer, Stage IIIA Cervical Cancer, Stage IIIB Cervical Cancer, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer
Trial Information
Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Description:
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.
Outcome 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
Safety Issue:
No
Principal Investigator
Agustin Garcia
Investigator Role:
Principal Investigator
Investigator Affiliation:
USC/Norris Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
5C-11-2
NCT ID:
NCT01676818
Start Date:
August 2012
Completion Date:
August 2015
Related Keywords:
- Recurrent Cervical Cancer
- Stage IIIA Cervical Cancer
- Stage IIIB Cervical Cancer
- Stage IVA Cervical Cancer
- Stage IVB Cervical Cancer
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles, California 90089 |
