Sunitinib Malate in Treating Patients With Locally Recurrent, Locally Advanced, Unresectable, or Metastatic Urinary Tract Cancer

Phase 2

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

• Registration Number: NCT01118039
• Lead Sponsor: Hospital del Mar

Brief Summary

RATIONALE: Sunitinib malate 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 the side effects of giving sunitinib malate and to see how well it works in treating patients with locally recurrent, locally advanced, unresectable, or metastatic urinary tract cancer.

Detailed Description

OBJECTIVES:

Primary

* To determine the time to disease progression (defined as the time from diagnosis of metastatic urothelial carcinoma until first confirmed progression of the disease) in patients with locally recurrent, locally advanced, unresectable, or metastatic urothelial cancer treated with sunitinib malate and ineligible for cisplatin-based chemotherapy.

* To determine the safety of this drug in these patients.

Secondary

* To determine the progression-free survival of patients treated with this drug.

* To determine the overall response rate in patients treated with this drug.

* To determine the overall survival of patients treated with this drug.

* To determine the time to treatment failure in patients treated with this drug.

* To determine the pharmacodynamic profile of this drug in pre- and post-treatment serum and tumor tissue (i.e., IL8, VEGF, MMP9, bFGF, p27, Ki-67, and apoptosis \[H/E\]) at week 6, and if possible, at time of progression.

* To determine the quality of life of patients treated with this drug using the QLQ-C30 version 3 questionnaire.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaire (EORTC QLQ-C30) before, during, and at the end of study treatment.

Serum and tumor tissue samples are collected at baseline and after study treatment for pharmacodynamic studies. Samples are analyzed for markers (i.e., IL8, VEGF, MMP9, bFGF, p27, Ki-67, and apoptosis \[H/E\]) via immunohistochemistry.

After completion of study treatment, patients are followed for 28 days and then every 2 months for up to 3 years.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-06
• Primary Completion: 2010-12
• Status Verified: 2012-09
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: UNKNOWN
• 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
Time to disease progression
Safety

Secondary Outcome Measures

Name	Time	Method
Overall response rate
Progression-free survival
Overall survival
Time to treatment failure
Pharmacodynamic profile
Quality of life

Trial Locations

Locations (4)

Hospital Universitario San Carlos; 🇪🇸 Madrid, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Hospital de la Santa Cruz i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain