Phase 2
N=32
Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer
Recurrent Cervical Cancer · Stage IIIA Cervical Cancer · Stage IIIB Cervical Cancer · Stage IVA Cervical Cancer · Stage IVB Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01676818 ↗Enrolled (actual)
32
Serious AEs
78.1%
Results posted
Nov 2025
Primary outcome: Primary: Progression-free Survival — 2.5 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- eribulin mesylate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Southern California
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
2.5 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
25 | — |
| SECONDARY Best Overall Response (BOR) |
1; 5; 13; 11 | — |
| SECONDARY Overall Survival (OS) |
6.5 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01676818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.