Eribulin + Chemotherapy for Bladder Cancer
Trial Summary
What is the purpose of this trial?
This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, paclitaxel, and sacituzumab govitecan work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, if you are taking strong or moderate CYP3A or CYP2C8 inhibitors or inducers, you may need to stop them at least 2 weeks before starting the trial if you are assigned to certain treatment groups.
What data supports the effectiveness of the drug combination Eribulin and chemotherapy for bladder cancer?
Research shows that combinations of drugs like docetaxel and gemcitabine have been used effectively in treating advanced bladder cancer, with promising results in terms of response rates. These drugs are part of the combination being studied, suggesting potential effectiveness for the new treatment.12345
Is the combination of Eribulin and chemotherapy safe for treating bladder cancer?
Studies have shown that the combination of gemcitabine and docetaxel, which are part of the chemotherapy regimen, has been evaluated for safety in treating advanced bladder cancer. These studies generally focus on the side effects and how well patients tolerate the treatment, indicating that while there are side effects, the treatment is considered manageable for many patients.25678
What makes the Eribulin + Chemotherapy treatment unique for bladder cancer?
Research Team
Sarmad Sadeghi
Principal Investigator
SWOG Cancer Research Network
Eligibility Criteria
This trial is for adults with metastatic urothelial cancer who've had platinum-based and PD1/PDL1 antibody therapy, possibly enfortumab vedotin. They should have good organ function, no immediate CNS treatment needs, not be pregnant or breastfeeding, and willing to use contraception. Excluded are those with recent gemcitabine progression or unresolved toxicities from past treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive chemotherapy regimens based on the arm they are randomized to, with cycles repeating every 21 or 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 6 months for 2 years, then annually until death or 3 years from registration.
Treatment Details
Interventions
- Docetaxel
- Eribulin Mesylate
- Gemcitabine Hydrochloride
- Paclitaxel
Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor