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AZD6244 in Treating Patients With Recurrent or Persistent Endometrial Cancer

2014-08-27 03:18:03 | BioPortfolio

Summary

RATIONALE: AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well AZD6244 works in treating patients with recurrent or persistent endometrial cancer.

Description

OBJECTIVES:

Primary

- To assess the activity of MEK inhibitor AZD6244, in terms of progression-free survival rate for ≥ 6 months after initiating therapy or objective response rate, in patients with recurrent or persistent endometrial carcinoma.

- To determine the nature and degree of toxicity of this regimen in these patients as assessed by NCI CTCAE v3.0.

Secondary

- To determine the duration of progression-free survival and overall survival of patients treated with this regimen.

Exploratory

- To explore the association between select biomarkers and response to MEK inhibitor AZD6244 (progression-free survival status > 6 months and objective tumor response), measures of clinical outcome (progression-free survival and overall survival), or disease status, including histologic cell type.

- To explore the relationship among a panel of biomarkers, including mutations and single nucleotide polymorphisms in BRAF, KRAS2, FGFR2, PI3KCA, AKT1, AKT2, AKT3, and PTEN as well as immunohistochemical expression of ERK, pERK, GSK3β, pGSK3β, PR-A, PR-B, pPR, ERα, ERβ, BRAF, KRAS, PTEN, EGFR, pEGFR, EGF, PELP1, and MTA1s.

OUTLINE: This is a multicenter study.

Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood and archived tumor tissue samples are collected for biomarker studies.

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

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Endometrial Cancer

Intervention

MEK inhibitor AZD6244, laboratory biomarker analysis

Location

University of Colorado Cancer Center at UC Health Sciences Center
Aurora
Colorado
United States
80045

Status

Suspended

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:03-0400

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Medical and Biotech [MESH] Definitions

Neoplasms of the endometrial stroma that sometimes involve the MYOMETRIUM. These tumors contain cells that may closely or remotely resemble the normal stromal cells. Endometrial stromal neoplasms are divided into three categories: (1) benign stromal nodules; (2) low-grade stromal sarcoma, or endolymphatic stromal myosis; and (3) malignant endometrial stromal sarcoma (SARCOMA, ENDOMETRIAL STROMAL).

A hereditary disease characterized by multiple ectodermal, mesodermal, and endodermal nevoid and neoplastic anomalies. Facial trichilemmomas and papillomatous papules of the oral mucosa are the most characteristic lesions. Individuals with this syndrome have a high risk of BREAST CANCER; THYROID CANCER; and ENDOMETRIAL CANCER. This syndrome is associated with mutations in the gene for PTEN PHOSPHATASE.

The extension of endometrial tissue (ENDOMETRIUM) into the MYOMETRIUM. It usually occurs in women in their reproductive years and may result in a diffusely enlarged uterus with ectopic and benign endometrial glands and stroma.

Tumors or cancer of ENDOMETRIUM, the mucous lining of the UTERUS. These neoplasms can be benign or malignant. Their classification and grading are based on the various cell types and the percent of undifferentiated cells.

Benign proliferation of the ENDOMETRIUM in the UTERUS. Endometrial hyperplasia is classified by its cytology and glandular tissue. There are simple, complex (adenomatous without atypia), and atypical hyperplasia representing also the ascending risk of becoming malignant.

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