Sunitinib Malate in Treating Patients With Locally Recurrent, Locally Advanced, Unresectable, or Metastatic Urinary Tract Cancer
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.
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: sunitinib malate
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: quality-of-life assessment
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Assessing SU-011248 in Previously Untreated Patients With Advanced Urothelial Cancer Ineligible for Cisplatin-Based Chemotherapy|
- Time to disease progression [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall response rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Pharmacodynamic profile [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- 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.
|Hospital de la Santa Cruz i Sant Pau||Recruiting|
|Barcelona, Spain, 08025|
|Contact: Contact Person 34-93-553-7118 email@example.com|
|Hospital Del Mar||Recruiting|
|Barcelona, Spain, 08003|
|Contact: Contact Person 34-39-3248-3861 XVillanueva@imas.imim.es|
|Hospital Universitario 12 de Octubre||Recruiting|
|Madrid, Spain, 28041|
|Contact: Contact Person 34-91-469-2313 firstname.lastname@example.org|
|Hospital Universitario San Carlos||Recruiting|
|Madrid, Spain, 28040|
|Contact: Contact Person 34-91-330-3000, Ext. 7935 email@example.com|
|Investigator:||Joaquim Bellmunt, MD, PhD||Hospital del Mar|