Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer

University of Southern California

Status and phase: Completed; Phase 2

Conditions: Stage IVA Cervical Cancer; Stage IIIB Cervical Cancer; Recurrent Cervical Cancer; Stage IVB Cervical Cancer; Stage IIIA Cervical Cancer

Treatments: Drug: eribulin mesylate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01676818

NCI-2012-01378 (Registry Identifier)

5C-11-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Eribulin mesylate

Experimental group

Description:

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.

Treatment:

Drug: eribulin mesylate