VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urot… (NCT00407485) | Clinical Trial Compass
CompletedPhase 2
VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urothelium
United States22 participantsStarted 2006-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 c…
What they're measuring
1
Tumor Response Rate
Timeframe: From the start of the treatment until disease progression or recurrence, assessed up to 4 years
2
Progression-free Survival (PFS)
Timeframe: From start of treatment to time of progression, assessed up to 4 months