A Phase II Study of Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer
We will combine an oral investigational VEGF inhibitor called papopanib which is being studied in kidney cancer will be combined with standard chemotherapy called taxol in patients with relapsed recurrent urothelial cancer.
- drug : Paclitaxel
- drug : Pazopanib (GW786034)
Phase: Phase 2
Ages Eligible For Study:
1. 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 2. First recurrence after treatment with a maximum of two chemotherapeutic regimens. 3. 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. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol. 4. Age >= 18 years 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Measurable disease criteria by RECIST criteria 7. Adequate organ system function as defined below 1. Absolute neutrophil count (ANC) >= 1.5 X 10^9/L 2. Hemoglobin >= 9 g/dL 3. Platelets >= 100 X 10^9/L 4. Prothrombin time (PT) or international normalized ratio (INR) <= 1.2 X upper limit of normal (ULN) 5. Total bilirubin <= 1.5 X ULN 6. AST and ALT <= 2.5 X ULN 7. Serum creatinine <= 1.8 mg/dL 8. Urine Protein to Creatinine Ratio (UPC) <1 8. A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant). This includes any female who has had: - A hysterectomy - A bilateral oophorectomy (ovariectomy) - A bilateral tubal ligation - Menopause Childbearing potential females must have a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agree to use adequate contraception. Adequate acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow: - An intrauterine device with a documented failure rate of less than 1% per year. - Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female. - Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product. - Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).