Entry Detail
| General information | |
| Database: | DB00565 |
| Objective: | A 2stagephase II study was conducted to assess the activity and toxicity profile of pazopanib in patients with metastatic, urothelial carcinoma. |
| Authors: | Pili R, et al |
| Title: | a phase II safety and efficacy study of the vascular endothelial growth factor receptor tyrosine kinase inhibitor pazopanib in patients with metastatic urothelial cancer. |
| Journal: | Clin Genitourin Cancer |
| Year: | 2013 |
| PMID: | 23891158 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | pazopanib |
| Target: | Plateletderived growth factor receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 |
| Cancer Type: | Urothelial Carcinoma |
| Cancer Subtype: | transitional cell carcinoma of the urothelium |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II Safety and Efficacy Study |
| Key Patients Feature: | Patients with histologically or cytologically confirmed transitionalcell carcinoma of the urothelium/bladder, with the predominanthistologic component being transitional cell carcinoma, wereeligible. Prior adjuvant/neoadjuvant therapy was permitted, as wellas prior palliative radiation to metastatic lesion(s) provided there wasat least one measurable or evaluable lesion that had not been radiated. Inclusion criteria included age 18 years; Eastern CooperativeOncology Group performance status 2; life expectancy 12weeks; blood pressure < 140 mm Hg (systolic) < 90 mm Hg(diastolic); measureable disease with at least one lesion with thelongest diameter > 1.0 cm; at least 4 weeks elapsed since priorradiation therapy; a maximum of one prior chemotherapy regimenfor metastatic disease; and adequate hematologic, hepatic, and renalfunction. This included absolute neutrophil count 1500/mm3, platelets 100, 000/mm3, white blood cell count 3000 cells/mm3, measured creatinine clearance 60 mL/min/1.73 m2, totalbilirubin equal to or less than normal institutional limits, prothrombin time (PTT)/international normalized ratio/activatedPTT 1.2 times the upper limit of normal, and aspartate aminotransferase (serum glutamic oxaloacetic transaminase) or alanineaminotransferase (serum glutamic pyruvic transaminase) 2.5 timesthe institutional upper limit of normal. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received pazopanib at a dose of 800 mg orally for a 4week cycle. |
| Primary End Point: | tumor response |
| Secondary End Point: | NA |
| Patients Number: | 19 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.9 months |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | No grade 4 or 5 events were experienced. Nine patients experienced 11 grade 3 adverse events. Most common toxicities were anemia, thrombocytopenia, leucopenia, and fatigue. |
| Conclusions: | Pazopanib did not show significant activity in patients with urothelial carcinoma. The role of antiVEGF therapies in urothelial carcinoma may need further evaluation in rational combination strategies. |