Recurrent Cervical CancerPhase 2NCT01676818
Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer
A Phase 2 study testing eribulin mesylate in people with Recurrent Cervical Cancer and Stage IIIA Cervical Cancer, run by University of Southern California at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Cervical Cancer, Stage IIIA Cervical Cancer, Stage IIIB Cervical Cancer
- What is being tested?
- eribulin mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2012to 22 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
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
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the activity of eribulin (eribulin mesylate) in the management of advanced or recurrent cervical cancer (progression-free survival [PFS].
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Recurrent Cervical Cancer, Stage IIIA Cervical Cancer, Stage IIIB Cervical Cancer, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer
- Being tested
- eribulin mesylate
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eribulin mesylateDrug
Also called B1939, E7389, ER-086526, halichrondrin B analog
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Eribulin mesylate | Experimental | 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. Receives: Drug: eribulin mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death. It is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up.
Measured: From the first day of treatment to the first observation of disease progression or death due to any cause, assessed at 6 months
Number of Participants With Serious Adverse Events (SAEs)
Safety evaluation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.3 was used to grade all SAEs. Grade 3+ hematologic and non-hematologic toxicities are reported.
Measured: At study drug administration until 30 days following the last dose. Assessed up to 2 years.
Secondary outcomes (2)
Best Overall Response (BOR)
BOR is defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
Measured: Every 6 weeks from start of treatment until occurrence of progressive disease, assessed up to 4 years.
Overall Survival (OS)
Overall survival is defined as the time from first day of treatment to time of death due to any cause. If a patient is still alive, survival time is censored at the time of last follow-up.
Measured: From first day of treatment to time of death due to any cause, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study start9 Aug 2012
- Primary completion21 Feb 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lynda Roman, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676818
- Sponsor's protocol ID
- 5C-11-2
- Other IDs
- NCI-2012-01378
- Status last verified
- Oct 2025
- First submitted
- 29 Aug 2012
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
- ClinicalTrials.gov ID
- NCT01676818
- Acronym / sponsor ID
- 5C-11-2
- Conditions
- Recurrent Cervical Cancer, Stage IIIA Cervical Cancer, Stage IIIB Cervical Cancer, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Aug 2012 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the activity of eribulin (eribulin mesylate) in the management of advanced or recurrent cervical cancer (progression-free survival [PFS].
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin mesylate | Experimental | Drug: eribulin mesylateEribulin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eribulin mesylateAlso: B1939, E7389, ER-086526, halichrondrin B analogGiven IV | Drug | Eribulin mesylate |
Primary outcome
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
Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death. It is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: At study drug administration until 30 days following the last dose. Assessed up to 2 years.
Safety evaluation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.3 was used to grade all SAEs. Grade 3+ hematologic and non-hematologic toxicities are reported.
2 secondary outcomes
Best Overall Response (BOR)
Time frame: Every 6 weeks from start of treatment until occurrence of progressive disease, assessed up to 4 years.
Overall Survival (OS)
Time frame: From first day of treatment to time of death due to any cause, assessed up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynda Roman, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing eribulin mesylate in people with Recurrent Cervical Cancer and Stage IIIA Cervical Cancer, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.