Clinical trial · Interventional
Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer
Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
NCT01676818CI-TRIAL-00097031completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eribulin mesylate | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Eribulin mesylate
- 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.
- interventionNames
- Drug: eribulin mesylate
Primary outcomes (2)
- 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
- description
- 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.
- measure
- Number of Participants With Serious Adverse Events (SAEs)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.