Pazopanib Hydrochloride in Treating Patients With Metastatic Urethral Cancer or Bladder Cancer That Has Relapsed or Not Responded to Treatment

Phase 2

Completed

• Conditions: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer

• Registration Number: NCT01031875
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* To evaluate the activity of daily oral doses of pazopanib hydrochloride monotherapy in patients with relapsed/refractory metastatic urothelial carcinoma or transitional cell tumors.

Secondary

* 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.

Tertiary

* 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 Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-13
• Study First Submitted QC: 2009-12-13
• Study First Posted: 2009-12-15
• Primary Completion: 2011-12
• Study Completion: 2012-08
• Status Verified: 2012-09
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate (complete and partial response) according to RECIST 1.1 criteria

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability, in terms of incidence, nature, and severity of treatment-related adverse events according to CTCAE v4.0
Progression-free survival

Trial Locations

Locations (1)

Fondazione Istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy