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A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies

2014-08-27 03:18:39 | BioPortfolio

Summary

Primary Objectives To evaluate the safety and activity of administering a combination of two antineoplastic agents, erlotinib and 5-azacytidine, in an effort to inhibit multiple operative growth factor pathways directly and via epigenetic mechanisms, as therapy for the treatment of advanced or metastatic cancer, as determined by the quality and quantity of adverse events.

Secondary Objectives To evaluate the response to treatment as determined by the achievement of an objective tumor response, progression-free survival and overall survival.

Description

Same as above

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Advanced Solid Tumor Malignancies

Intervention

5-azacytidine, erlotinib

Location

University of New Mexico Cancer Center
Albuquerque
New Mexico
United States
87106

Status

Recruiting

Source

New Mexico Cancer Care Alliance

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:39-0400

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Medical and Biotech [MESH] Definitions

An alkylating agent of value against both hematologic malignancies and solid tumors.

A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.

Tumor suppressor genes located on human chromosome 9 in the region 9p21. This gene is either deleted or mutated in a wide range of malignancies. (From Segen, Current Med Talk, 1995) Two alternatively spliced gene products are encoded by p16: CYCLIN-DEPENDENT KINASE INHIBITOR P16 and TUMOR SUPPRESSOR PROTEIN P14ARF.

The condition of a pattern of malignancies within a family, but not every individual's necessarily having the same neoplasm. Characteristically the tumor tends to occur at an earlier than average age, individuals may have more than one primary tumor, the tumors may be multicentric, usually more than 25 percent of the individuals in direct lineal descent from the proband are affected, and the cancer predisposition in these families behaves as an autosomal dominant trait with about 60 percent penetrance.

A neoplasm composed entirely of GRANULOSA CELLS, occurring mostly in the OVARY. In the adult form, it may contain some THECA CELLS. This tumor often produces ESTRADIOL and INHIBIN. The excess estrogen exposure can lead to other malignancies in women and PRECOCIOUS PUBERTY in girls. In rare cases, granulosa cell tumors have been identified in the TESTES.

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