Sunitinib Malate in Treating Patients With Locally Recurrent, Locally Advanced, Unresectable, or Metastatic Urinary Tract Cancer
|ClinicalTrials.gov Identifier: NCT01118039|
Recruitment Status : Unknown
Verified September 2012 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 6, 2010
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: sunitinib malate Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study Procedure: quality-of-life assessment||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Assessing SU-011248 in Previously Untreated Patients With Advanced Urothelial Cancer Ineligible for Cisplatin-Based Chemotherapy|
|Study Start Date :||July 2006|
|Estimated Primary Completion Date :||December 2010|
- Time to disease progression
- Progression-free survival
- Overall response rate
- Overall survival
- Time to treatment failure
- Pharmacodynamic profile
- Quality of life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118039
|Hospital Del Mar||Recruiting|
|Barcelona, Spain, 08003|
|Contact: Contact Person 34-39-3248-3861 XVillanueva@imas.imim.es|
|Hospital de la Santa Cruz i Sant Pau||Recruiting|
|Barcelona, Spain, 08025|
|Contact: Contact Person 34-93-553-7118 firstname.lastname@example.org|
|Hospital Universitario San Carlos||Recruiting|
|Madrid, Spain, 28040|
|Contact: Contact Person 34-91-330-3000, Ext. 7935 email@example.com|
|Hospital Universitario 12 de Octubre||Recruiting|
|Madrid, Spain, 28041|
|Contact: Contact Person 34-91-469-2313 firstname.lastname@example.org|
|OverallOfficial:||Joaquim Bellmunt, MD, PhD||Hospital del Mar|