Clinical trial NCT01676818: Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer
Official title: Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Cervical Cancer
Stage IIIA Cervical Cancer
Stage IIIB Cervical Cancer
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-08-31
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Progression-free survival
timeFrame: From the first day of treatment to the first observation of disease progression or death due to any cause, assessed at 6 months
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Best overall response (BOR)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: From first day of treatment to time of death due to any cause, assessed up to 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Lynda Roman, MD
role: PRINCIPAL_INVESTIGATOR
References: