Phase II Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer (NCT01108055) | Clinical Trial Compass
CompletedPhase 2
Phase II Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer
United States43 participantsStarted 2010-04
Plain-language summary
We will combine an oral investigational vascular endothelial growth factor (VEGF inhibitor) called pazopanib which is being studied in kidney cancer will be combined with standard chemotherapy called taxol in patients with relapsed recurrent urothelial cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra). Mixed histology is allowed as long as the predominant histology is TCC
✓. First recurrence after treatment with a maximum of two chemotherapeutic regimens.
✓. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up.
✓. Age ≥ 18 years
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
✓. Measurable disease criteria by RECIST criteria
✓. Adequate organ system function as defined below
✓. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
Exclusion criteria
✕. History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer Malignancies that have undergone a putative surgical cure (ie, localized prostate cancer post-prostatectomy) within 5 years prior to Day 1 may be discussed with the Medical Monitor
✕. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug.