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

2014-08-27 03:13:54 | BioPortfolio

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.

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 Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Bladder Cancer

Intervention

sunitinib malate, immunohistochemistry staining method, laboratory biomarker analysis, pharmacological study, quality-of-life assessment

Location

Hospital de la Santa Cruz i Sant Pau
Barcelona
Spain
08025

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:54-0400

Clinical Trials [2659 Associated Clinical Trials listed on BioPortfolio]

Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. PURPOSE: This phase II trial ...

Magnetic Resonance Imaging (MRI) in Predicting Response to Sunitinib Malate in Patients With Locally Advanced or Metastatic Kidney Cancer

Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment. Purpose: This clinical trial is studying MRI in...

Sunitinib in Treating Patients With Locally Advanced Bladder Cancer

RATIONALE: Sunitinib 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. Giving sunitinib before surgery may ...

Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer

This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread to nea...

Sunitinib in Treating Patients With Newly Diagnosed Stage II or Stage III Breast Cancer That Can Be Removed by Surgery

RATIONALE: Sunitinib 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. Giving sunitinib before surgery may ...

PubMed Articles [26280 Associated PubMed Articles listed on BioPortfolio]

Development of a validated LC-MS/MS method for the in vitro and in vivo quantitation of sunitinib in glioblastoma cells and cancer patients.

Sunitinib is a multi-targeted tyrosine kinase inhibitor approved for the treatment of renal cell carcinoma and imatinib-resistant gastrointestinal stromal tumor and is currently being investigated aga...

Evaluation of a new commercial method for von Willebrand factor multimeric analysis.

Evaluation of von Willebrand factor (VWF) multimeric distribution is useful for subclassification of von Willebrand disease (VWD). Multimer analysis has historically been a manual, labor-intensive lab...

Segmentation of glandular epithelium in colorectal tumours to automatically compartmentalise IHC biomarker quantification: A deep learning approach.

In this paper, we propose a method for automatically annotating slide images from colorectal tissue samples. Our objective is to segment glandular epithelium in histological images from tissue slides ...

PD-L1 immunostaining scoring for non-small cell lung cancer based on immunosurveillance parameters.

Non-Small Cell Lung Cancer (NSCLC) is the leading cause of cancer death globally, and new immunotherapies developed and under development targeting PD-1/PD-L1 checkpoint inhibition require accurate pa...

NT5E inhibition suppresses the growth of sunitinib-resistant cells and EMT course and AKT/GSK-3β signaling pathway in renal cell cancer.

We aimed to explore the mechanisms of sunitinib-resistance in renal cell cancer (RCC) and provide new therapeutic evidence and biomarkers for RCC treatment using human clear-cell renal cell carcinoma ...

Medical and Biotech [MESH] Definitions

An enzyme that catalyzes the conversion of (S)-malate and NAD+ to oxaloacetate and NADH. EC 1.1.1.37.

A method of chemical analysis based on the detection of characteristic radionuclides following a nuclear bombardment. It is also known as radioactivity analysis. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

A light-activated enzyme that catalyzes the oxidation of (S)-malate to OXALOACETATE. It is involved in PYRUVATE metabolism and CARBON fixation.

An important enzyme in the glyoxylic acid cycle which reversibly catalyzes the synthesis of L-malate from acetyl-CoA and glyoxylate. This enzyme was formerly listed as EC 4.1.3.2.

The analysis of an activity, procedure, method, technique, or business to determine what must be accomplished and how the necessary operations may best be accomplished.

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