Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Metastatic Bladder Urothelial Carcinoma
  • Metastatic Renal Pelvis Urothelial Carcinoma
  • Metastatic Ureter Urothelial Carcinoma
  • Stage IV Ureter Cancer AJCC v8
  • Metastatic Urethral Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Stage IV Renal Pelvis Cancer AJCC v8
  • Stage IV Urethral Cancer AJCC v8
  • Stage IVB Bladder Cancer AJCC v8
  • Stage IVA Bladder Cancer AJCC v8
  • Refractory Bladder Urothelial Carcinoma
  • Refractory Renal Pelvis Urothelial Carcinoma
  • Refractory Ureter Urothelial Carcinoma
  • Refractory Urethral Urothelial Carcinoma
  • Refractory Urothelial Carcinoma
  • Stage IV Renal Pelvis and Ureter Cancer AJCC v8
  • Stage IV Bladder Cancer AJCC v8
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To compare overall survival (OS) in participants with metastatic urothelial carcinoma (mUC) who are randomized to standard treatment versus eribulin mesylate (eribulin) alone. II. To compare overall survival in participants with metastatic urothelial carcinoma (mUC) who are ra...

PRIMARY OBJECTIVES: I. To compare overall survival (OS) in participants with metastatic urothelial carcinoma (mUC) who are randomized to standard treatment versus eribulin mesylate (eribulin) alone. II. To compare overall survival in participants with metastatic urothelial carcinoma (mUC) who are randomized to standard treatment versus eribulin plus gemcitabine hydrochloride (gemcitabine). III. To compare overall survival in participants with metastatic urothelial carcinoma (mUC) who are randomized to eribulin alone versus eribulin plus gemcitabine. SECONDARY OBJECTIVES: I. To compare progression-free survival (PFS) in the standard treatment arm to the two experimental treatment arms in this population. II. To compare Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 overall response rate (ORR), both confirmed and unconfirmed, complete and partial responses (CR and PR), in the standard treatment arm to the two experimental treatment arms in the subset of participants with measurable disease in this population. III. To compare duration of response (DOR) in the standard treatment arm to the two experimental treatment arms in the subset of participants with measurable disease in this population. IV. To compare disease control rate (DCR) in the standard treatment arm to the two experimental treatment arms in the subset of participants with measurable disease in this population. BANKING OBJECTIVE: I. To bank specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive 1 of the 3 standard of care chemotherapy regimens based on treating investigator's choice: Choice A: Patients receive docetaxel intravenously (IV) on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice B: Patients receive gemcitabine IV on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Choice C: Patients receive paclitaxel IV on days 1, 8, and 15. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive eribulin IV over 2-5 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM III: Patients receive eribulin IV over 2-5 minutes and gemcitabine IV on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years from the date of registration, then every 12 months until death or 3 years from the date of registration

Tracking Information

NCT #
NCT04579224
Collaborators
Not Provided
Investigators
Principal Investigator: Sarmad Sadeghi Southwest Oncology Group