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Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

2014-08-27 03:42:26 | BioPortfolio

Summary

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.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus.

Description

OBJECTIVES:

Primary

- Assess the activity of sunitinib malate, in terms of rate of progression-free survival for ≥ 6 months and objective tumor response, in patients with recurrent or persistent leiomyosarcoma of the uterus who have received 1 or 2 prior cytotoxic therapies.

- Determine the frequency and severity of adverse events.

Secondary

- Determine the duration of progression-free survival and overall survival.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Sarcoma

Intervention

sunitinib malate

Location

Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham
Alabama
United States
35294

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:26-0400

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PubMed Articles [107 Associated PubMed Articles listed on BioPortfolio]

Tricarboxylic acid cycle without malate dehydrogenase in Streptomyces coelicolor M-145.

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Enhancement of malate production through engineering of the periplasmic rTCA pathway in E. coli.

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Analytical aspects of sunitinib and its geometric isomerism towards therapeutic drug monitoring in clinical routine.

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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 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.

An enzyme that catalyzes the first step in the biosynthetic pathway to LEUCINE, forming isopropyl malate from acetyl-CoA and alpha-ketoisovaleric acid. This enzyme was formerly listed as EC 4.1.3.12.

An experimental sarcoma of mice.

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