Pazopanib Hydrochloride in Treating Patients With Metastatic Urethral Cancer or Bladder Cancer That Has Relapsed or Not Responded to Treatment
RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works in treating patients with or metastatic urothelial cancer or bladder cancer that has relapsed or not responded to treatment.
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: pazopanib hydrochloride Radiation: fludeoxyglucose F 18||Phase 2|
|Study Design:||Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase 2 Study With the Multi-Targeted Tyrosine-Kinase Inhibitor Pazopanib (GW786034) for Patients With Relapsed or Refractory Urothelial Cancer|
- Response rate (complete and partial response) according to RECIST 1.1 criteria
- Safety and tolerability, in terms of incidence, nature, and severity of treatment-related adverse events according to CTCAE v4.0
- Progression-free survival
|Study Start Date:||December 2009|
|Study Completion Date:||August 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- To evaluate the activity of daily oral doses of pazopanib hydrochloride monotherapy in patients with relapsed/refractory metastatic urothelial carcinoma or transitional cell tumors.
- To evaluate the safety and tolerability of pazopanib hydrochloride monotherapy in a population of chemotherapy pretreated patients.
- To assess progression-free survival of these patients.
- To evaluate the ability of whole-body 18FDG-PET to image metastases and monitor tumor response and to determine the rate of concordance with CT imaging and RECIST response criteria.
- To evaluate the relationship existing between tumor response measured by 18FDG-PET and progression-free survival.
OUTLINE: This is a multicenter study.
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo whole-body 18FDG-PET at baseline and periodically.
After completion of study treatment, patients are followed for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031875
|Fondazione Istituto Nazionale dei Tumori|
|Milan, Italy, 20133|
|Study Chair:||Roberto Salvioni, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|
|OverallOfficial:||Nicola Nicolai, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|
|OverallOfficial:||Andrea Necchi, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|