Pazopanib Hydrochloride in Treating Patients With Metastatic Urethral Cancer or Bladder Cancer That Has Relapsed or Not Responded to Treatment
|ClinicalTrials.gov Identifier: NCT01031875|
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: pazopanib hydrochloride Radiation: fludeoxyglucose F 18||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study With the Multi-Targeted Tyrosine-Kinase Inhibitor Pazopanib (GW786034) for Patients With Relapsed or Refractory Urothelial Cancer|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||August 2012|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|