Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Clinical Trial
Official title:
Phase II Trial of Gemcitabine-Eribulin (GE) in Cisplatin Ineligible Patients With Advanced or Unresectable Urothelial Carcinoma of the Bladder
This phase II trial studies how well gemcitabine hydrochloride and eribulin mesylate work in treating patients with bladder cancer that has spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and eribulin mesylate, 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.
PRIMARY OBJECTIVES:
I. To estimate the objective response rate of gemcitabine (gemcitabine
hydrochloride)-eribulin (eribulin mesylate) (GE) when given to cisplatin ineligible patients
with advanced or unresectable urothelial carcinoma who have not received any prior
chemotherapy for the advanced disease.
SECONDARY OBJECTIVES:
I. To estimate the median progression-free survival (PFS). II. To summarize the toxicity
profile (using Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 criteria)
of the GE regimen in these patients.
OUTLINE:
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8
and eribulin mesylate IV 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 up to 36
months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT00365157 -
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03244384 -
Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT02812420 -
Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery
|
Early Phase 1 | |
| Withdrawn |
NCT03419130 -
Radiation Therapy and Pembrolizumab in Treating Patients With Localized Urothelial Bladder Cancer
|
Phase 2 | |
| Recruiting |
NCT05987241 -
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study
|
Phase 3 | |
| Active, not recruiting |
NCT03047213 -
Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations
|
Phase 2 | |
| Completed |
NCT03421652 -
Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo
|
Phase 2 |