Trials / Completed
CompletedNCT00407485
VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urothelium
A Phase II Study of VEGF Trap (NSC 724770) in Patients With Recurrent or Metastatic Transitional Carcinoma of the Urothelium
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with recurrent, locally advanced, or metastatic cancer of the urothelium. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor.
Detailed description
PRIMARY OBJECTIVES: I. Determine the response rate in patients with recurrent, locoregionally advanced, or metastatic transitional cell carcinoma of the urothelium treated with VEGF Trap. II. Determine the time to progression in patients treated with this drug. III. Determine overall survival of patients treated with this drug. IV. Determine the tolerability and safety of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection periodically during study for pharmacokinetic/pharmacodynamic correlative studies. After completion of study treatment, patients are followed periodically.
Conditions
- Adenocarcinoma of the Bladder
- Distal Urethral Cancer
- Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
- Proximal Urethral Cancer
- Recurrent Bladder Cancer
- Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
- Recurrent Urethral Cancer
- Squamous Cell Carcinoma of the Bladder
- Stage III Bladder Cancer
- Stage III Urethral Cancer
- Stage IV Bladder Cancer
- Transitional Cell Carcinoma of the Bladder
- Urethral Cancer Associated With Invasive Bladder Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ziv-aflibercept | Given IV |
| OTHER | pharmacological study | Correlative studies |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2010-04-01
- Completion
- 2014-04-01
- First posted
- 2006-12-05
- Last updated
- 2014-10-20
- Results posted
- 2014-10-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00407485. Inclusion in this directory is not an endorsement.