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Alkylating agents

Bevacizumab for Ureter Cancer

Phase 3
Waitlist Available
Led By Jonathan E Rosenberg
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights

Study Summary

This trial is comparing the standard treatment for advanced urinary tract cancer (gemcitabine and cisplatin) to the standard treatment plus bevacizumab. The goal is to see if adding bevacizumab makes the treatment more effective.

Eligible Conditions
  • Urothelial Carcinoma
  • Ureter Cancer
  • Urethral Cancer
  • Prostate Cancer
  • Renal Pelvis Cancer
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Number of Patients Experiencing Grade 3+ Toxicity
Objective Response
Progression-free Survival (PFS)

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (gemcitabine hydrochloride, cisplatin, bevacizumab)Experimental Treatment4 Interventions
Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (gemcitabine hydrochloride, cisplatin, placebo)Active Control4 Interventions
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,646 Previous Clinical Trials
40,930,521 Total Patients Enrolled
Jonathan E RosenbergPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer
2009. "Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00942331.
~32 spots leftby Apr 2025
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