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.
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: pazopanib hydrochloride
Radiation: fludeoxyglucose F 18
|Study Design:||Allocation: Non-Randomized
Masking: 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|