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

Completed · Phase 2

Conditions studied: 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

In brief

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 facts

Study ID

NCT00407485

Run by

National Cancer Institute (NCI)

People needed

22

Starts

2006-11-01

Expected to finish

2014-04-01

Last updated by the study team

2014-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed transitional cell carcinoma (TCC) of the urothelium
• Must have predominance of transitional histology, but foci of squamous and/or adenocarcinoma histology allowed
• Poorly differentiated transitional cell carcinoma allowed
• TCC of any of the following sites allowed:
• Bladder
• Renal pelvis
• Ureter
• Urethra
• Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
• Locoregionally advanced or metastatic disease that is not amenable to curative surgery and/or radiotherapy
• Must have received 1 prior systemic chemotherapy regimen containing a platinum compound (e.g., cisplatin, carboplatin, or oxaliplatin) in the neoadjuvant, adjuvant, or metastatic setting
• No evidence of CNS disease, including primary brain tumor or brain metastases
• ECOG performance status 0-2
• Absolute neutrophil count >= 1,000/mm\^3
• Platelet count >= 75,000/mm\^3
• Bilirubin =< 1.5 times upper limit of normal (ULN)
• AST or ALT =< 2.5 times ULN
• Creatinine =< 2.5 times ULN OR creatinine clearance => 40 mL/min
• Urine protein: creatinine ratio =< 1 OR 24-hour urine protein < 500 mg
• INR =< 1.5 (unless on full-dose warfarin)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for >= 6 months after completion of study treatment
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to other agents used in the study

Where it is running

• City of Hope — Duarte, California, United States

Full record on ClinicalTrials.gov

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