VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urothelium

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00407485
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ziv-aflibercept — BIOLOGICAL
    Given IV
  • pharmacological study — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Nov 30, 2006
Status verified
Oct 2013
Primary completion
Apr 30, 2010
Completion
Apr 30, 2014

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ziv-aflibercept)
    Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Tumor Response Rate [ Time Frame: From the start of the treatment until disease progression or recurrence, assessed up to 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-

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