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About
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.
Full 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.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Histologically confirmed transitional cell carcinoma (TCC) of the urothelium
TCC of any of the following sites allowed:
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
No serious or nonhealing wound, ulcer, or bone fracture
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
No significant traumatic injury within the past 28 days
No clinically significant cardiovascular disease, including any of the following:
No evidence of bleeding diathesis or coagulopathy
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
Recovered from prior therapy
Prior biologic or targeted therapies allowed
No more than 1 prior systemic chemotherapy regimen for metastatic disease
No prior antiangiogenic therapy primarily targeting the vascular endothelial growth factor pathway
At least 4 weeks since prior radiotherapy or systemic therapy (6 weeks for mitomycin C or nitrosoureas)
More than 28 days since prior major surgery or open biopsy
More than 7 days since prior core biopsy
No concurrent major surgery
Concurrent full-dose anticoagulants (e.g., warfarin) allowed provided all of the following criteria are met:
No other concurrent investigational agents
No concurrent combination antiretroviral therapy for HIV-positive patients
Primary purpose
Allocation
Interventional model
Masking
22 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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